A Phase 3 interventional study of GIE Medical ProTractX3 TTS DCB and Control in Bowel; Stricture, sponsored by GIE Medical. Recruiting at 33 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by GIE Medical · Phase 3, Interventional, and Treatment
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 171 is above the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →GIE Medical is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Combination Product: GIE Medical ProTractX3 TTS DCB
Standard of Care.
Other: Control
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Standard of Care Endoscopic Dilation
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Time frame: 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)
Time frame: 30 Days Post-Treatment
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
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
Surgery Free Survival
Time frame: 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
Technical Success
Time frame: 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
Dilations per year before and after treatment
Time frame: 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
Estimated stricture diameter
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Plan to share: Undecided
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