Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel (PATENT-B)

GIE Medical

Status and phase: Enrolling; Phase 3

Conditions: Bowel; Stricture

Treatments: Other: Control; Combination Product: GIE Medical ProTractX3 TTS DCB

Study type: Interventional

Funder types: Industry

Identifiers

NCT05561127

PR2053

Details and patient eligibility

About

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Enrollment: 171 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 22
2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
3. Willing and able to complete protocol required follow up
4. Willing and able to provide written informed consent
5. Stricture length ≤ 5 cm

Exclusion criteria

1. Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
2. Contraindication to endoscopy, anesthesia, or deep sedation.
3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator.
4. Benign stricture due to extrinsic compression
5. Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
6. Stricture complicated with abscess, fistula, perforation, leakage or varices
7. Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers >0.5cm in diameter, ulcerated surface >10%, affected (inflamed) surface >50%, marked erythema, absent vascular pattern, significant friability, or erosions
8. Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) NOTE: Clinically significant strictures include those that are unable to be passed by the endoscope.
9. Received steroid injections into target stricture in the last 8 weeks
10. Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel
11. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer)
12. Suspected perforation of gastrointestinal tract
13. Active systemic infection
14. Allergy to paclitaxel
15. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
16. Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
17. Condition requiring treatment in urgent setting
18. Life expectancy of less than 24 months
19. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, etc.
20. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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171 participants in 2 patient groups

GIE Medical ProTractX3 TTS DCB

Experimental group

Description:

The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Treatment:

Combination Product: GIE Medical ProTractX3 TTS DCB

Control

Active Comparator group

Description:

Standard of Care.

Treatment:

Other: Control