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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05561114
Other study ID # PR2052
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 1, 2023
Est. completion date December 1, 2029

Study information

Verified date April 2024
Source GIE Medical
Contact Erika Wang
Phone 7633605659
Email wange@giemedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 198
Est. completion date December 1, 2029
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: 1. Age = 22 years 2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations, at least one of which occurred in the last 12 months and achieved a diameter of 15mm 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 (e.g. 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 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


Intervention

Combination Product:
GIE Medical ProTractX3 TTS DCB
Paclitaxel Coated Balloon
Other:
Control
Standard Endoscopic Dilation

Locations

Country Name City State
United States University of Colorado Anschutz Aurora Colorado
United States Birmingham Gastroenterology Associates Birmingham Alabama
United States University of North Carolina Chapel Hill Chapel Hill North Carolina
United States Rush University Chicago Illinois
United States Peak Gastroenterology Colorado Springs Colorado
United States University of Florida Gainesville Florida
United States Borland-Groover Jacksonville Florida
United States University of Louisville Louisville Kentucky
United States Gastroenterology Associates of Central Georgia, LLC Macon Georgia
United States Tandem Clinical Research Marrero Louisiana
United States Vanderbilt University Medical Center Nashville Tennessee
United States New York Presbyterian Hospital- Columbia University Medical Center New York New York
United States Arkansas Gastroenterology North Little Rock Arkansas
United States Orlando Health Orlando Florida
United States Thomas Jefferson University Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Allegheny Health Network Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States The University of Utah Salt Lake City Utah
United States Swedish Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
GIE Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Success Freedom from 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 6 Months Post-Procedure
Primary Primary Safety Outcome Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion) 30 Days Post-Treatment
Secondary Freedom from symptom recurrence 6 Months Post-Procedure
Secondary Freedom from clinically driven reintervention The rate of subjects free from clinically driven repeat intervention for the stricture treated at the index procedure in each arm will be assessed via Kaplan-Meier survival analysis. 6 Months Post-Procedure
Secondary Ogilvie Dysphagia Score =1 without clinically driven repeat intervention 6 Months Post-Procedure
Secondary Improvement in Ogilvie Dysphagia Score 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary Improvement in Dysphagia Handicap Index score 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary Minimum esophageal stricture diameter 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary Number of esophageal dilation procedures 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary Freedom from clinical driven reintervention 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary Freedom from symptom recurrence 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary VAS for pain scores 30 Day Follow-up
Secondary Composite EQ-5D quality of life scores 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary Dilations per year before and after treatment 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary Time between dilations 30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
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