Clinical Trials in the USA / NCT05561114
Recruiting
Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
NCT05561114 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Esophageal Stricture
Investigational drug(s) / intervention(s)
GIE Medical ProTractX3 TTS DCBControl
GIE Medical ProTractX3 TTS DCB: Paclitaxel Coated Balloon
Control: Standard Endoscopic Dilation
Study summary
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Eligibility
Inclusion Criteria:
1. Age ≥ 22 years
2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations
3. Ogilvie Dysphagia Score of ≥2
4. Minimum esophageal lumen diameter \<13 mm
5. Willing and able to complete protocol required follow-up visits
6. Willing and able to provide written informed consent
7. Strictures ≤5cm in total length
8. Target benign esophageal stricture etiologies include:
1. Peptic stricture,
2. Schatzki's ring,
3. Stricture due to prior infection,
4. Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture
5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy
Exclusion Criteria:
1. Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon.
2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
3. Contraindication to endoscopy, anesthesia or deep sedation
4. Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment.
5. History of diagnosis of eosinophilic esophagitis (EoE)
6. Signs or suspicion of a malignant esophageal stricture NOTE: If stricture is suspicious for malignancy based on clinical or endoscopic presentation, malignancy must be excluded by biopsy prior to enrollment. Subjects with a history of invasive esophageal cancer should have recurrence excluded by advanced imaging (e.g. CT/PET scan) and biopsy within 6 months of enrollment.
7. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the neck or thoracic region NOTE: A prior diagnosis of esophageal cancer is acceptable if considered in remission and recurrence has been excluded by advanced imaging and biopsy within 6 months of enrollment.
8. Suspected perforation of gastrointestinal tract
9. Inability to pass guidewire across stricture
10. Active systemic infection
11. Allergy to paclitaxel or structurally related compounds
12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
13. Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
14. Received steroid injections into target stricture in the last 8 weeks.
15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator
16. Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function.
17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation)
18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc
19. Life expectancy of less than 24 months
20. 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, ongoing infection, etc
21. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.
22. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc.
23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.
24. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.
25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists)
26. Concurrent gastric and/or duodenal obstruction
Primary outcome measure(s)
- Treatment Success — 6 Months Post-Procedure
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 - Primary Safety Outcome — 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)
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Birmingham Gastroenterology Associates | Birmingham | Alabama | Not Yet Recruiting |
| Honor Health | Scottsdale | Arizona | Recruiting |
| University of California, Irvine | Irvine | California | Recruiting |
| Gastro Care Institute | Lancaster | California | Recruiting |
| Cedars Sinai | Los Angeles | California | Recruiting |
| San Diego Gastroenterology | San Diego | California | Recruiting |
| University of Colorado Anschutz | Aurora | Colorado | Recruiting |
| University of Florida | Gainesville | Florida | Recruiting |
| Borland-Groover | Jacksonville | Florida | Recruiting |
| Research Associates of South Florida | Miami | Florida | Recruiting |
| Hillcrest Medical Research | Orange City | Florida | Recruiting |
| Orlando Health | Orlando | Florida | Recruiting |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | Recruiting |
| Rush University | Chicago | Illinois | Recruiting |
| Kansas Gastroenterology, LLC | Wichita | Kansas | Recruiting |
| University of Louisville | Louisville | Kentucky | Recruiting |
| Tandem Clinical Research | Marrero | Louisiana | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Sierra Clinical Research | Las Vegas | Nevada | Recruiting |
| Rutgers University | Piscataway | New Jersey | Recruiting |
| New York Presbyterian Hospital- Columbia University Medical Center | New York | New York | Recruiting |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| Oregon Health and Science University | Portland | Oregon | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Einstein Medical Center | Philadelphia | Pennsylvania | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Recruiting |
| Allegheny Health Network | Pittsburgh | Pennsylvania | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Baylor St. Luke's Medical Center | Houston | Texas | Recruiting |
| TEN20 Clinical Research | Plano | Texas | Recruiting |
| The University of Utah | Salt Lake City | Utah | Recruiting |
| Swedish Medical Center | Seattle | Washington | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
More GIE Medical trials in the USA
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05561114 on ClinicalTrials.gov ↗ ← All trials in the USA