Bowel; StricturePhase 3PATENT-BNCT05561127
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
A Phase 3 study testing GIE Medical ProTractX3 TTS DCB in people with Bowel; Stricture, run by GIE Medical at 33 sites in United States.
Trial summary
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Bowel; Stricture
- What is being tested?
- GIE Medical ProTractX3 TTS DCB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 33 sitesUnited States
- Study dates
- 1 Nov 2023to 1 Jun 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 22
- Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
- Willing and able to complete protocol required follow up
- Willing and able to provide written informed consent
- Stricture length ≤ 5 cm
Who cannot join
- Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
- Contraindication to endoscopy, anesthesia, or deep sedation.
- 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.
- Benign stricture due to extrinsic compression
- Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
- Stricture complicated with abscess, fistula, perforation, leakage or varices
Show all 20Show fewer
- 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
- 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.
- Received steroid injections into target stricture in the last 8 weeks
- Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel
- 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)
- Suspected perforation of gastrointestinal tract
- Active systemic infection
- Allergy to paclitaxel
- Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
- 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
- Condition requiring treatment in urgent setting
- Life expectancy of less than 24 months
- 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.
- Current participation in another pre-market drug or medical device clinical study unless in long term follow-up
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
United States33 sites, 33 recruiting
- Recruiting
University of Colorado Anschutz
Aurora, Colorado, 80045
Carter Stovall, 303.724.9228, carter.stovall@cuanschutz.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Samantha Geltz, sgeltz@bwh.harvard.edu
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599-1350
Emily English, emily_english@med.unc.edu
- Recruiting
Rush University
Chicago, Illinois, 60612
Maria Guzman, maria_E_guzman@rush.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
April Goddard, 352-273-9472, april.goddard@medicine.ufl.edu
- Recruiting
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Elaheh Boroujeni, elaheh.keivaniboroujeni@bcm.edu
- Recruiting
University of California, Irvine
Irvine, California, 92697-7600
Hector Ochoa, hcochoa@hs.uci.edu
- Recruiting
Borland-Groover
Jacksonville, Florida, 32256
Cynthia Buda, 904-680-0871, cbuda@encoredocs.com
- Recruiting
Gastro Care Institute
Lancaster, California, 93534
Ruben Vargas, rvargas@gciav.com
- Recruiting
Cedars Sinai
Los Angeles, California, 90048
Claudia Bancilla, liliana.bancila@cshs.org
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Angela Siegwald, (502) 852-2043, angela.siegwald@louisville.edu
- Recruiting
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31210
Elizabeth Jones, 4177182100, ejones@gaocg.com
- Recruiting
Tandem Clinical Research
Marrero, Louisiana, 70072
Antoinette Hymel, (504) 934-8424, ahymel@tandemclinicalresearch.com
- Recruiting
Research Associates of South Florida
Miami, Florida, 33134
Nicole Rieth, nrieth@researchassociatesfl.com
- Recruiting
West Virginia University
Morgantown, West Virginia, 26501
Caitlin Regner, caitlin.regner@hsc.wvu.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 27232
Larry Raber, larry.w.raber@vumc.org
- Recruiting
New York Presbyterian Hospital- Columbia University Medical Center
New York, New York, 10027
Claudia Musat, 212-305-3009, cm2065@cumc.columbia.edu
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Rachel Maggi, : (212) 434-3346, rmaggi@northwell.edu
- Not yet recruiting
Hillcrest Medical Research
Orange City, Florida, 32763
Larry Moulder, 0000000000, lmoulder@hillcrestmedicalresearch.com
- Recruiting
Orlando Health
Orlando, Florida, 32806
Anna Hernandez, (321) 841-6649, anna.hernandez@orlandohealth.com
- Recruiting
Orlando Health
Orlando, Florida, 32806
Anna Hernandez, anna.hernandez@orlandohealth.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Christine Gepty, 215-349-8527, christine.gepty@pennmedicine.upenn.edu
- Recruiting
Einstein Medical Center
Philadelphia, Pennsylvania, 19107
Stacey Carmody, stacy.carmody@jefferson.edu
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Manisha Verma, (267) 234-1528, manisha.verma@jefferson.edu
- Recruiting
Rutgers University
Piscataway, New Jersey, 08854
Molly Stewart, molly.stewart1@rutgers.edu
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Brianna Smith, 4122288310, brianna.smith@ahn.org
- Recruiting
The University of Utah
Salt Lake City, Utah, 84108
Amy Nichols, 8015879050, amy.nichols@hsc.utah.edu
- Recruiting
San Diego Gastroenterology
San Diego, California, 92103
Nancy Giovanetty, nancy@sdgastro.com
- Recruiting
Honor Health
Scottsdale, Arizona, 85258
Victoria Staenglen, vstaenglen@honorhealth.com
- Recruiting
Virginia Mason
Seattle, Washington, 98101
Emily Chesterfield, emily.chesterfield@commonspirit.org
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Adel Islam, 206.386.3201, adel.islam@swedish.org
- Recruiting
Washington University
St Louis, Missouri, 63130
Thomas Hollander, hollandert@wustl.edu
- Recruiting
Kansas Gastroenterology, LLC
Wichita, Kansas, 67226
Jessica Wewer, jessica_wewer@ksgastro.com
About this study
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
- Conditions
- Bowel; Stricture
- Being tested
- GIE Medical ProTractX3 TTS DCB, Control
- Keywords
- dcb, bowel stricture, drug coated balloon, paclitaxel coated balloon
- Medical subject headings
- Constriction, Pathologic, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIE Medical ProTractX3 TTS DCBCombination product
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
ControlOther
Standard of Care Endoscopic Dilation
| Study group | Role | What they receive |
|---|---|---|
| GIE Medical ProTractX3 TTS DCB | Experimental | The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter. Receives: Combination Product: GIE Medical ProTractX3 TTS DCB |
| Control | Active comparator | Standard of Care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of > 1 when using a pediatric colonoscope or equivalent
Measured: 6 Months Post-Treatment
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Measured: 30 Days Post-Treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 Months Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Nov 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel; StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GIE Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561127
- Sponsor's protocol ID
- PR2053
- Acronym
- PATENT-B
- Status last verified
- Jun 2025
- First submitted
- 27 Sep 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
- ClinicalTrials.gov ID
- NCT05561127
- Acronym / sponsor ID
- PATENT-B / PR2053
- Conditions
- Bowel; Stricture
- Keywords
- dcb, bowel stricture, drug coated balloon, paclitaxel coated balloon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- GIE MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIE Medical ProTractX3 TTS DCB | Experimental | Combination Product: GIE Medical ProTractX3 TTS DCBThe ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter. |
| Control | Active comparator | Other: ControlStandard of Care. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 22
- Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
- Willing and able to complete protocol required follow up
- Willing and able to provide written informed consent
- Stricture length ≤ 5 cm
Key exclusion criteria (20 listed)
- Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
- Contraindication to endoscopy, anesthesia, or deep sedation.
- 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.
- Benign stricture due to extrinsic compression
- Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIE Medical ProTractX3 TTS DCBThe ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter. | Combination product | GIE Medical ProTractX3 TTS DCB |
| ControlStandard of Care Endoscopic Dilation | Other | Control |
Primary outcome
Freedom from Stricture Recurrence
Time frame: 6 Months Post-Treatment
Endoscopic Obstruction Scale (EOS) of > 1 when using a pediatric colonoscope or equivalent
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)
2 secondary outcomes
Freedom from clinically driven target stricture reintervention
Time frame: 6 Months Post-Procedure
Improvement in GIQLI-10 score
Time frame: 6 Months Post-Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GIE Medical ProTractX3 TTS DCB in people with Bowel; Stricture, run by GIE Medical at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Wang (0000000000, wange@giemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Stricture Recurrence (time frame: 6 Months Post-Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.