A Phase 3 interventional study of GIE Medical ProTractX3 TTS DCB and Control in Esophageal Stricture, sponsored by GIE Medical. Recruiting at 34 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 evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
47 studies on the registry are indexed under Esophageal Stenosis; 13 are open to participants now.
This study's planned enrollment of 198 is above the median of 30 across 36 interventional studies indexed under Esophageal Stenosis.
Browse Esophageal Stenosis 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.
Target benign esophageal stricture etiologies include:
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
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.
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.
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.
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.
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 Endoscopic Dilation
Other: Control
Paclitaxel Coated Balloon
Standard Endoscopic Dilation
Treatment Success
1\. The primary efficacy endpoint is freedom from stricture recurrence, measured as the time from Index procedure until stricture recurrence through 6 months post-procedure. Stricture recurrence is defined as an esophageal diameter \<13mm as measured using a functional luminal imaging probe, or clinically driven reintervention at the treated area within 6 months post-procedure as determined by the Clinical Events Committee
Time frame: 6 Months Post-Procedure
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
Annualized Rate of Reintervention
The annualized reintervention rate is defined as the annualized number of clinically driven interventions and will be assessed by comparing the annualized rate per patient year between groups using a test of Poisson rates.
Time frame: Annually
Diameter Improvement at 6 months
The minimum esophageal stricture diameter will be assessed by a functional luminal imaging probe (EndoFLIP) during endoscopy and compared between the Test and Control arms. The minimum esophageal stricture diameter will be measured at baseline and during the 6-month follow-up, or at the time of a reintervention if one occurs prior to 6 months.
Time frame: 6 Months Post-Procedure
Clinical Responder Rate at 6 months
Time frame: 6 Months Post-Procedure
Freedom from clinically driven target stricture reintervention through 6 months post-procedure
Time frame: 6 Months Post-Procedure
Freedom from symptom recurrence through 6 months post-procedure
Time frame: 6 Months Post-Procedure
Secondary Patency
Time frame: Time between the index procedure to the second clinically driven intervention
Technical Success
Time frame: Procedure
Annualized rate of dilations before and after treatment
Time frame: Annually
Improvement in time between dilations
Time frame: Between Dilations
Improvement in Ogilvie Dysphagia Score at each follow-up
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Improvement in Dysphagia Handicap Index score at each follow-up
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Stricture characteristics per functional imaging
Time frame: Between Dilations
Number of esophageal dilation procedures through each follow up
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Freedom from clinically driven reintervention through each follow-up
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Freedom from symptom recurrence through each follow-up
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
VAS for pain scores through 30-day follow-up
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Composite EQ-5D quality of life scores at each follow-up
Time frame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Plan to share: No
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