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Recruiting Phase 3

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

NCT05561114 · tracked via the Priya Life Science USA tracker
Sponsor
GIE Medical
Phase
Phase 3
Started
2023-12-01
Last updated
2025-06-25

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

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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