NCT05561127ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.

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In brief

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

Phase 3171 participants sought33 sites1 country

Registered in 1 registry

ClinicalTrials.govNCT05561127Open this record at ClinicalTrials.govSynced 2 months ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-09-30; recorded start 2023-11-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (GIE Medical)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding7/20
Single-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type7/10
Clinical-event endpoint
Multi-centre8/8
Multi-centre: 33 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study: 171 participants (target), run at 33 sites.

How this score is built

Enrolment21/40
171 participants (target)
Site count18/25
33 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 105 months
Sponsor scale2/10
GIE Medical has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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

Conditions

Bowel; Stricture

Eligibility

Eligibility
Sex	All
Ages	22 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	SINGLE (1)
Enrolment	171 participants sought

Sponsor and collaborators

GIE Medical Sponsor

Arms and interventions

GIE Medical ProTractX3 TTS DCBEXPERIMENTAL
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
ControlACTIVE_COMPARATOR
Standard of Care.

Interventions

Other Control
Standard of Care Endoscopic Dilation
Combination product GIE Medical ProTractX3 TTS DCB
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Outcome measures

Primary outcome
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Time frame 6 Months Post-Treatment
Primary outcome
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Time frame 30 Days Post-Treatment
Secondary outcome
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.
Time frame 6 Months Post-Procedure
Secondary outcome
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.
Time frame 6 Months Post-Procedure
Other outcome
Surgery Free Survival
Time frame 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Other outcome
Improvement in GIQLI-10
Time frame 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Other outcome
Technical Success
Time frame 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Other outcome
Improvement in EOS
Time frame 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Other outcome
Dilations per year before and after treatment
Time frame 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Other outcome
Time between dilations
Time frame 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Other outcome
Estimated stricture diameter
Time frame 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

Dates

Dates
Start date	November 1, 2023 (actual)
Primary completion	December 1, 2027 (estimated)
Completion	June 1, 2032 (estimated)
First posted	September 30, 2022 (actual)
Last updated	June 25, 2025
Results posted	Not stated in the registry record
Status last verified	June 2025

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

32 sites are recruiting

United States

United States
Facility	City	State or region	Status
University of Colorado Anschutz	Aurora	Colorado	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
University of North Carolina	Chapel Hill	North Carolina	Recruiting
Rush University	Chicago	Illinois	Recruiting
University of Florida	Gainesville	Florida	Recruiting
Baylor St. Luke's Medical Center	Houston	Texas	Recruiting
University of California, Irvine	Irvine	California	Recruiting
Borland-Groover	Jacksonville	Florida	Recruiting
Gastro Care Institute	Lancaster	California	Recruiting
Cedars Sinai	Los Angeles	California	Recruiting
University of Louisville	Louisville	Kentucky	Recruiting
Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia	Recruiting
Tandem Clinical Research	Marrero	Louisiana	Recruiting
Research Associates of South Florida	Miami	Florida	Recruiting
West Virginia University	Morgantown	West Virginia	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
Lenox Hill Hospital	New York	New York	Recruiting
New York Presbyterian Hospital- Columbia University Medical Center	New York	New York	Recruiting
Hillcrest Medical Research	Orange City	Florida	Not yet recruiting
Orlando Health	Orlando	Florida	Recruiting
Orlando Health	Orlando	Florida	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
Einstein Medical Center	Philadelphia	Pennsylvania	Recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	Recruiting
Rutgers University	Piscataway	New Jersey	Recruiting
Allegheny Health Network	Pittsburgh	Pennsylvania	Recruiting
The University of Utah	Salt Lake City	Utah	Recruiting
San Diego Gastroenterology	San Diego	California	Recruiting
Honor Health	Scottsdale	Arizona	Recruiting
Virginia Mason	Seattle	Washington	Recruiting
Swedish Medical Center	Seattle	Washington	Recruiting
Washington University	St Louis	Missouri	Recruiting
Kansas Gastroenterology, LLC	Wichita	Kansas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05561127

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

United States

Study documents

Changes over time