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SpaceIT^™ Hydrogel�Prostate-Rectum Spacer

Physician Application Training Module

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Agenda

At the end of this course you will:

Discuss the intended use for SpaceIT™ Hydrogel.
Describe the pre-application process.
List the steps of device preparation & application.
List the warnings associated with SpaceIT™ Hydrogel application.
State the proper handling & storage steps for SpaceIT™ Hydrogel.

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SpaceIT^™ Hydrogel Intended Use

SpaceIT^™ Hydrogel

Temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer.¹
Designed to reduce the radiation dose delivered to the anterior rectum.*
Composed of a radiopaque, biodegradable material.¹
Designed to completely absorb into the patient’s body over time.*

*To be validated in clinical trial

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Allergy Considerations

SpaceIT™ Hydrogel contains PEG and Iodine.

The use of this product for patients with documented sensitivities or allergic reactions �has not been studied and should be considered carefully on a case-by-case basis.¹

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SpaceIT vs SpaceOAR Vue

SpaceIT Hydrogel

SpaceOAR Vue Hydrogel

*Images on file with Boston Scientific

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SpaceOAR Vue vs. SpaceIT

	SpaceOAR Vue Hydrogel	SpaceIT Hydrogel
Composition	PEG hydrogel with bound iodine	PEG hydrogel with bound iodine
Formulation	In-situ polymerizing	Pre-polymerized hydrogel particles
MRI Visibility
CT/CBCT Visibility
Ultrasound Visibility	Has air artifact	No air artifact

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Pre-application

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Required Equipment

Ultrasound unit with real-time Side-fire trans-rectal ultrasound (TRUS) probe: Allows undistorted visibility without compressing the perirectal space
Stepper: Holds and stabilizes the TRUS probe allowing both hands to be free
10cc syringe and sterile saline: For hydrodissection - opening the plane between Denonvilliers’ fascia and anterior rectal wall to verify needle position
Sterile drape and sterile gloves: For SpaceIT^™ Hydrogel application assembly

Side-fire TRUS probe

Floor mounted stepper

Saline Flush

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Pre-Procedure Checklist

Pre-Procedure

Review the patient's medical history.

Ensure patient bowel prep is completed.

Per physician protocol, preferred prescriptions are administered.

Equipment and supplies are prepared in a sterile field.

Positioning:

Patient in dorsal lithotomy position.
Ultrasound for optimal visibility.

Anesthesia administered(local, GA, MAC).

Transperineal fiducial marker placement.

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Patient Positioning

The patient should be in dorsal lithotomy position.
Hips between 45-90° for access to the perirectal space.
Patient position should minimize movement during procedure for best hydrogel placement.
Lowering the patient's legs can lower the rectal hump and give easier access to the perirectal fat plane.

Images are from URO-6777202-AA

Before lowering the legs

After lowering the legs

Image is from anaskey.com

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Factors impacting perirectal spacer Hydrogel distribution

Probe Angle

Apex Compressed

(flow to base)

Base Compressed

(flow to apex

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Factors impacting perirectal spacer Hydrogel distribution

Probe Height

Probe too high

(little midline gel)

Probe too low

(gel ball)

Needle on Midline

(bilateral distribution)

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Factors impacting perirectal spacer Hydrogel distribution

Other potential factors:

Abnormal anatomy
Injection speed
Perirectal fibrosis
Needle tip location �(toward base or apex)

Needle Position

Needle off Midline

(lateral distribution)

Probe just right

(even gel thickness)

Needle on Midline

(bilateral distribution

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SpaceIT^TM Hydrogel Device Preparation

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SpaceIT™ Hydrogel Device Description

Device Description:

SpaceIT™ Hydrogel System consists of sterile, single-use components to deliver absorbable, radiopaque perirectal spacer.
Two pre-filled glass syringes with endcaps contain the pre-polymerized PEG hydrogel.
18G x 15cm Stainless steel needle with marked hub.
The plastic Luer Connector with silicon O-rings (hereafter referred to as Luer Connector) facilitates mixing the hydrogel between the two glass syringes immediately prior to use.
SpaceIT™ Hydrogel contains 10 mL. of hydrogel

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Device Preparation Steps 1-4

Using sterile technique, transfer contents of SpaceIT™ Hydrogel into the sterile field.

NOTE: the packing is not sterilized.

Remove endcap from each pre-filled glass syringe.

Attach the Luer Connector to either pre-filled glass syringe.

Expel extra air from both pre-filled glass syringes (Figure 2).

Ensure to expel only air and not the SpaceIT™ Hydrogel.

Figure 2. Expel extra air from both pre-filled syringes.

SpaceIT Hydrogel

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Device Preparation Step 5

Connect the two syringes via the Luer Connector (Figure 3).

Figure 3. Completed assembly for mixing.

Luer

Connector

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Device Preparation Step 6

Grasp the connected syringes in one hand keeping two fingers around the middle of both syringes.

With one hand, slowly depress the plunger to move the entire contents from one syringe to the other.

The gel will move into the other syringe. The plunger will move outward as the syringe is filled.

Make sure all gel contents are moved into the other syringe.

Figure 4. Grasp the connected syringes in one hand

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Device Preparation Step 7

While holding both syringes, rotate your wrist to turn the connected syringes 180° (Figure 5).

Figure 5. Rotate wrist to turn the connected syringes 180°

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Device Preparation Steps 8

Depress the plunger on the full syringe, moving the gel back into the other syringe. The plunger will move outward as the syringe is filled. Ensure all gel contents are moved into the other syringe.

Precaution: Please do not transfer Hydrogel between syringes more than indicated in Steps 6 to 8. Overmixing may result in excessive air bubbles which may affect the ultrasound image.

Figure 5. Rotate wrist to turn the connected syringes 180°

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Device Preparation Steps 9

Remove the hydrogel-filled glass syringe from the Luer Connector. Discard the �empty glass syringe with the Luer Connector.

Figure 5. Rotate wrist to turn the connected syringes 180°

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Device Application

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Warning – When to Discontinue Procedure

SPACE

The perirectal space does not open during �hydrodissection.

LOCATION

The needle enters the rectal lumen at any time during the procedure.

BLOOD

Blood is aspirated into the syringe �when verifying needle tip is not in a blood vessel.

VISIBILITY

Hydrogel is not seen in the perirectal space during injection.

Discontinue the procedure immediately if any of the following occurs:

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Hydrodissection: Needle Placement

Insert Needle

Prime the needle to remove all air.
The blue marking on the needle hub will be facing up and visible to the user when correctly oriented, with needle bevel facing down.
Insert 1-2 cm anterior to the anal opening.
Angle the needle as needed to reach the perirectal fat between the anterior rectal wall and the prostate.

Needle tip

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Hydrodissection: Needle Placement

Insert Needle (cont.)

Advance needle through the rectourethralis muscle to the perirectal fat at the middle of the prostate gland.
Avoid piercing the rectal wall with the needle as the needle advances.
Confirm midline and mid-gland needle tip position in sagittal and axial views and verify that the needle tip is in the perirectal fat.

Needle tip

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Hydrodissection: Base to Apex

Hydrodissection

In Sagittal view, inject small amounts of saline between the prostate and rectum to confirm needle location.

Switch to axial view and inject small amounts of saline to confirm needle location is midline.

Confirm the perirectal space has opened from the base of the prostate to the apex.

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Hydrodissection: Base to Apex

Hydrodissection (cont.)

If the space has not opened at the base, advance the needle tip to the base of the prostate while staying midline.

Aspirate to ensure needle tip is not intravascular.

If needle tip is not in the correct location, reposition the needle.

Excessive resistance experienced during hydrodissection or SpaceIT™ Hydrogel injection may indicate the needle tip is in an unintended location.

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Hydrodissection on Ultrasound

Key Points:

Use small amounts of saline.

You should see clear anechoic signal.

There should not have resistance when injecting.

Aspirate to ensure needle tip is not intravascular.

If needle tip is not in the correct location, reposition the needle.

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SpaceIT™ Hydrogel Placement

Attach SpaceIT™ syringe

Stabilize needle hub

Detach saline syringe

Purge extra air bubbles at the tip of delivery syringe if present

Attach SpaceIT™ Hydrogel syringe to 18G needle

Confirm needle position has not moved

Begin dispensing SpaceIT™

Sagittal View: With the needle at the midline base of the prostate gland, use a smooth controlled injection technique to dispense 1-2 mL of SpaceIT™ Hydrogel.

Axial View: Confirm the location and space created by the sphere.

Sagittal View: Move the needle toward the prostate’s mid-gland and begin creating the second sphere using 4-6ml of SpaceIT™ Hydrogel.

Once these two spheres are created, assess further spacing needs in axial view

SpaceIT Injection 1

SpaceIT Injection 2

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Viewing SpaceIT™ placement �on ultrasound

SpaceIT

SpaceIT™ at base

SpaceIT™ at Midgland to apex

SpaceIT™ in axial view

*Images on file with Boston Scientific

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SpaceIT™ Hydrogel Placement Touch Up

Lateral needle movement in axial view

When creating space with the last 1-2mL of hydrogel, a higher injection pressure may be required.

Such higher force is expected and not an affirmed indicator of an incorrect needle location. Always use ultrasound guidance to confirm needle location

*Image on file with Boston Scientific

SpaceIT

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SpaceIT™ Hydrogel Placement Touch Up

Touch up

Using the ultrasound axial view, identify if SpaceIT™ Hydrogel has covered the desired locations between the prostate and rectum from base to apex.

If previous spheres did not create adequate spacing, move the needle tip to the desired location while staying within an existing sphere and inject 1-2ml of SpaceIT™ Hydrogel to create coverage.
Repeat this step until desired space is created.

Do not use more than 1 syringe of SpaceIT™ Hydrogel in the perirectal fat space.

Only advance the needle using the sagittal view.

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Hydrogel Placement Key Points

Key Points:

Inject small amounts (1ml) at one time and continually assess where gel is placed.

Move needle completely outside of base injection before starting midgland injection.

Do not move needle while injecting SpaceIT.

Do not inject SpaceIT outside of existing sphere during touch up.

Adjust needle depth in Sagittal view.

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Post Procedure Imaging – CT and MRI

CT Scan

MRI Scan

*Image on file with Boston Scientific

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Handling and Storage

The product must be stored at room temp < 25°C/77°F and above 10°C (50°F) to maintain product performance.

(The polymer can melt at extreme temperatures, i.e., 38°C/100°F)

Keep the product dry.
Product is single use only – do not attempt to reuse or re-sterilize. �
Shelf life 12 months.

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Review

SpaceIT™ Hydrogel is composed of PEG based iodinated biodegradable material.
Designed to reduce the radiation dose delivered to the anterior rectum.
Patient position should be in a dorsal lithotomy with the ultrasound probe placed midline during the procedure.
Probe angle, probe height and needle angle can affect hydrogel placement.
Hydrodissection is used to confirm the space between the prostate and rectum before injecting hydrogel.
Excessive resistance experienced during hydrodissection or SpaceIT™ Hydrogel injection may indicate the needle tip is in an unintended location. Reassess needle position.
Inject SpaceIT at the prostate base and midgland before beginning to touch up. Continue to assess hydrogel placement throughout the procedure.
Do not use more than 1 syringe of SpaceIT™ Hydrogel in the perirectal fat space.

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Questions?

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Disclaimers

SpaceIT™ Hydrogel contains PEG. The use of this product in patients with documented PEG sensitivities or allergies has not been studied. The use of SpaceIT™ Hydrogel in patients with a known allergy to PEG could potentially lead to allergic reaction (including anaphylaxis).
SpaceIT™ Hydrogel contains iodine. The use of this product in patients with documented iodine sensitivities or allergies has not been studied. The risks and benefits of the decision to use in patients with a documented iodine allergy should be carefully considered on a case-by-case basis.

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References

SpaceIT Hydrogel System Instructions for use 51520676-01
SpaceOAR™ Hydrogel and SpaceOAR Vue™ Hydrogel Prostate-Rectum Spacers Physician Application training module URO-752104-AC

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