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

Phase 3

Recruiting

• Conditions: Esophageal Stricture
• Interventions: Combination Product: GIE Medical ProTractX3 TTS DCB; Other: Control

• Registration Number: NCT05561114
• Lead Sponsor: GIE Medical

Brief Summary

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2023-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-07
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GIE Medical ProTractX3 TTS DCB	GIE Medical ProTractX3 TTS DCB	The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Control	Control	Standard of Care Endoscopic Dilation

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Annualized Rate of Reintervention	Annually	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.
Diameter Improvement at 6 months	6 Months Post-Procedure	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.
Clinical Responder Rate at 6 months	6 Months Post-Procedure
Freedom from clinically driven target stricture reintervention through 6 months post-procedure	6 Months Post-Procedure
Freedom from symptom recurrence through 6 months post-procedure	6 Months Post-Procedure

Trial Locations

Locations (34)

Birmingham Gastroenterology Associates; 🇺🇸 Birmingham, Alabama, United States

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

Gastro Care Institute; 🇺🇸 Lancaster, California, United States

Cedars Sinai; 🇺🇸 Los Angeles, California, United States

San Diego Gastroenterology; 🇺🇸 San Diego, California, United States

University of Colorado Anschutz; 🇺🇸 Aurora, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Borland-Groover; 🇺🇸 Jacksonville, Florida, United States

Research Associates of South Florida; 🇺🇸 Miami, Florida, United States

Hillcrest Medical Research; 🇺🇸 Orange City, Florida, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Gastroenterology Associates of Central Georgia, LLC; 🇺🇸 Macon, Georgia, United States

Rush University; 🇺🇸 Chicago, Illinois, United States

Kansas Gastroenterology, LLC; 🇺🇸 Wichita, Kansas, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Tandem Clinical Research; 🇺🇸 Marrero, Louisiana, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Washington University; 🇺🇸 St Louis, Missouri, United States

Sierra Clinical Research; 🇺🇸 Las Vegas, Nevada, United States

Rutgers University; 🇺🇸 Piscataway, New Jersey, United States

New York Presbyterian Hospital- Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Allegheny Health Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States

TEN20 Clinical Research; 🇺🇸 Plano, Texas, United States

The University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States