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

• Sponsor: GIE Medical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05561127
• Collaborator: (none)
• Enrollment: 171
• Arms: 2
• Anticipated Duration (Months): 64

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bowel; Stricture	Combination Product: GIE Medical ProTractX3 TTS DCB; Other: Control	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Mar 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GIE Medical ProTractX3 TTS DCB The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.	Combination Product: GIE Medical ProTractX3 TTS DCB; The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Active Comparator: Control Standard of Care.	Other: Control; Standard of Care Endoscopic Dilation

Outcome Measures

Primary Outcome Measures

1. Anatomic Success [6 Months Post-Treatment]

   Endoscopic Obstruction Scale (EOS) of ≤1 when using a pediatric colonoscope or equivalent (outer diameter 12mm ± 0.5mm) without clinically driven repeat intervention prior to the close of the 6-month window.

2. Primary Safety Outcome [30 Days Post-Treatment]

   Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)

Secondary Outcome Measures

1. Freedom from clinically driven target stricture reintervention [6 Months Post-Procedure]

   Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms.

2. Improvement in GIQLI-10 score [6 Months Post-Procedure]

   The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire developed as a health-related quality of life assessment tool for patients with gastrointestinal diseases. The items on the GIQLI-10 align closely with common obstructive symptoms found in patients with bowel strictures.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, deep ulceration, perforation, leakage or varices

7. Multiple clinically significant strictures separated by greater than 5 cm

8. Received steroid injections into target stricture in the last 4 weeks

9. Stricture is not able to be dilated to ≥12mm in small bowel or ≥15mm in large bowel

10. 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)

11. Suspected perforation of gastrointestinal tract

12. Active systemic infection

13. Allergy to paclitaxel

14. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines

15. 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

16. Condition requiring treatment in urgent setting

17. Life expectancy of less than 24 months

18. 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.

19. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GIE Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GIE Medical
• ClinicalTrials.gov Identifier: NCT05561127
• Other Study ID Numbers: PR2053
• First Posted: Sep 30, 2022
• Last Update Posted: Sep 30, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GIE Medical: dcb; bowel stricture; drug coated balloon; paclitaxel coated balloon
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

No Results Posted as of Sep 30, 2022