Clinical trial NCT05561114: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Official title: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Stricture
Keywords: esophageal stricture
drug coated balloon
DCB
paclitaxel coated balloon
Lead sponsor: GIE Medical
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 198
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: Treatment Success
timeFrame: 6 Months Post-Procedure
measure: Primary Safety Outcome
timeFrame: 30 Days Post-Treatment
Secondary outcomes:
measure: Annualized Rate of Reintervention
timeFrame: Annually
measure: Diameter Improvement at 6 months
timeFrame: 6 Months Post-Procedure
measure: Clinical Responder Rate at 6 months
timeFrame: 6 Months Post-Procedure
measure: Freedom from clinically driven target stricture reintervention through 6 months post-procedure
timeFrame: 6 Months Post-Procedure
measure: Freedom from symptom recurrence through 6 months post-procedure
timeFrame: 6 Months Post-Procedure
Other outcomes:
measure: Secondary Patency
timeFrame: Time between the index procedure to the second clinically driven intervention
measure: Technical Success
timeFrame: Procedure
measure: Annualized rate of dilations before and after treatment
timeFrame: Annually
measure: Improvement in time between dilations
timeFrame: Between Dilations
measure: Improvement in Ogilvie Dysphagia Score at each follow-up
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Improvement in Dysphagia Handicap Index score at each follow-up
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Stricture characteristics per functional imaging
timeFrame: Between Dilations
measure: Number of esophageal dilation procedures through each follow up
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Freedom from clinically driven reintervention through each follow-up
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Freedom from symptom recurrence through each follow-up
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: VAS for pain scores through 30-day follow-up
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Composite EQ-5D quality of life scores at each follow-up
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates
state: Alabama
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: San Diego
country: United States
facility: San Diego Gastroenterology
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Orange City
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Wichita
country: United States
facility: Kansas Gastroenterology, LLC
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: New York
country: United States
facility: New York Presbyterian Hospital- Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Plano
country: United States
facility: TEN20 Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: