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

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

Study Overview

• Status: Recruiting
• Conditions: Bowel; Stricture
• Intervention / Treatment: Combination product: GIE Medical ProTractX3 TTS DCB; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 171
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Recruiting
      • New York Presbyterian Hospital- Columbia University Medical Center
      • Contact: Claudia Musat; Phone Number: 212-305-3009; Email: cm2065@cumc.columbia.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny Health Network
      • Contact: Michael Anderson; Phone Number: 412-228-8310; Email: michael.anderson@ahn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Outcome	Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)	30 Days Post-Treatment
Freedom from Stricture Recurrence	Endoscopic Obstruction Scale (EOS) of > 1 when using a pediatric colonoscope or equivalent	6 Months Post-Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from clinically driven target stricture reintervention	Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms.	6 Months Post-Procedure
Improvement in GIQLI-10 score	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.	6 Months Post-Procedure

Other Outcome Measures

Outcome Measure	Time Frame
Surgery Free Survival	30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Improvement in GIQLI-10	30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Technical Success	30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Improvement in EOS	30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Dilations per year before and after treatment	30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Time between dilations	30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Estimated stricture diameter	30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

Collaborators and Investigators

• Sponsor: GIE Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: drug coated balloon; dcb; bowel stricture; paclitaxel coated balloon
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: PR2053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No