Clinical trial NCT03885310: INGEST I Pilot Study
Official title: Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Stricture
Lead sponsor: GIE Medical
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
2. Contraindication to endoscopy, anesthesia or deep sedation.
3. Benign esophageal stricture due to extrinsic esophageal compression.
4. Currently required chest radiation therapy.
5. Malignant esophageal stricture.
6. Stricture total length \> 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm
7. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, etc.
8. Active erosive esophagitis.
9. Present esophageal ulceration, perforation, leak, fistula, or varices.
10. Concurrent gastric and/or duodenal obstruction.
11. Active systemic infection.
12. Allergy to paclitaxel or any components of the delivery system.
13. Severe coagulation disorders or current use of anticoagulant for comorbidities.
14. Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
15. Received steroid injections into target stricture in the last 4 weeks
16. Intolerant to proton pump inhibitors.
17. Life expectancy of less than 12 months.
18. Unwilling or unable to comply with the follow-up study requirements.
19. Lacking capacity to provide informed consent.
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, recent laparotomy, pharyngeal or cervical deformity, etc.
21. Currently participation in another pre-market drug or medical device clinical study.

Primary outcomes:
measure: Incident of serious balloon dilation-related complications
timeFrame: 30 days
Secondary outcomes:
measure: Numbers of additional esophageal dilation procedures
timeFrame: 30 days, 3 months, 6 months, and 12 months
measure: Time to first dysphagia symptom recurrence
timeFrame: 30 days, 3 months, 6 months, and 12 months
measure: Improvement in dysphagia score
timeFrame: 30 days, 3 months, 6 months, and 12 months
measure: Esophageal stricture diameter
timeFrame: 30 days, 3 months, 6 months, and 12 months
measure: Technical success
timeFrame: Time of procedure
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Adventista Hospital
Study officials:
affiliation: Mayo Clinic
name: Kenneth Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: