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

June 19, 2025 updated by: GIE Medical
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

171

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
    • California
      • Irvine, California, United States, 92697-7600
        • Recruiting
        • University of California, Irvine
        • Contact:
      • Lancaster, California, United States, 93534
      • Los Angeles, California, United States, 90048
      • San Diego, California, United States, 92103
        • Recruiting
        • San Diego Gastroenterology
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Gainesville, Florida, United States, 32610
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Borland-Groover
        • Contact:
      • Miami, Florida, United States, 33134
      • Orange City, Florida, United States, 32763
      • Orlando, Florida, United States, 32806
    • Georgia
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Gastroenterology Associates Of Central Georgia, LLC
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Kansas
      • Wichita, Kansas, United States, 67226
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Marrero, Louisiana, United States, 70072
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Missouri
      • St Louis, Missouri, United States, 63130
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
      • New York, New York, United States, 10027
        • Recruiting
        • New York Presbyterian Hospital- Columbia University Medical Center
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-1350
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 27232
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Contact:
      • Seattle, Washington, United States, 98101
    • West Virginia
      • Morgantown, West Virginia, United States, 26501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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)
30 Days Post-Treatment
Freedom from Stricture Recurrence
Time Frame: 6 Months Post-Treatment
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
Time Frame: 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.
6 Months Post-Procedure
Improvement in GIQLI-10 score
Time Frame: 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.
6 Months Post-Procedure

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GIE Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2032

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 (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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