Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture

GIE Medical1 site in 1 country9 target enrollmentFebruary 24, 2019

ConditionsEsophageal Stricture

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophageal Stricture
Sponsor: GIE Medical
Enrollment: 9
Locations: 1
Primary Endpoint: Incident of serious balloon dilation-related complications
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

Detailed Description

The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on esophageal stricture. Up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Registry

clinicaltrials.gov

Start Date

February 24, 2019

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GIE Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 and ≤ 80 years.
•Benign esophageal stricture with diameter less than 10 mm (barium esophagram).
•Dysphagia score of 2 to 4 (Ogilvie Dysphagia Score).
•Recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions.
•Stricture total length ≤ 7 cm. Tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease.
•Ability to undergo periodic endoscopic follow-up.
•Voluntary participation and provided written informed consent.

Exclusion Criteria

•Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
•Contraindication to endoscopy, anesthesia or deep sedation.
•Benign esophageal stricture due to extrinsic esophageal compression.
•Currently required chest radiation therapy.
•Malignant esophageal stricture.
•Stricture total length \> 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm
•Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, etc.
•Active erosive esophagitis.
•Present esophageal ulceration, perforation, leak, fistula, or varices.
•Concurrent gastric and/or duodenal obstruction.

Outcomes

Primary Outcomes

Incident of serious balloon dilation-related complications

Time Frame: 30 days

Adverse events such as perforation, bleeding requiring intervention, severe pain during swallowing, infection requiring hospitalization or IV antibiotics, dysphagia requiring re-intervention at determined by the attending physician

Secondary Outcomes

Numbers of additional esophageal dilation procedures(30 days, 3 months, 6 months, and 12 months)
Time to first dysphagia symptom recurrence(30 days, 3 months, 6 months, and 12 months)
Improvement in dysphagia score(30 days, 3 months, 6 months, and 12 months)
Esophageal stricture diameter(30 days, 3 months, 6 months, and 12 months)
Technical success(Time of procedure)