INGEST I Pilot Study

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

Detailed Description
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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.

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

Conditions
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Esophageal Stricture

Intervention / Treatment
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* Device: GIE Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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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. Active systemic infection. Allergy to paclitaxel or any components of the delivery system. Severe coagulation disorders or current use of anticoagulant for comorbidities. Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use. Received steroid injections into target stricture in the last 4 weeks Intolerant to proton pump inhibitors. Life expectancy of less than 12 months. Unwilling or unable to comply with the follow-up study requirements. Lacking capacity to provide informed consent. 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. Currently participation in another pre-market drug or medical device clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB Treatment<br>Stricture patients treated by DCB | Device: GIE Drug Coated Balloon<br>* The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident of serious balloon dilation-related complications | 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of additional esophageal dilation procedures | Repeat stricture treatments | 30 days, 3 months, 6 months, and 12 months | 
| Time to first dysphagia symptom recurrence | Ogilvie Dysphagia Score will be used to assess subject's dysphagia symptom changes at follow-ups. The date of the first reported occurrence of dysphagia symptom will be used to derive the time to first dysphagia symptom recurrence. | 30 days, 3 months, 6 months, and 12 months | 
| Improvement in dysphagia score | Ogilvie Dysphagia Score will be used to assess subject's dysphagia symptom changes at follow-ups. The scores at each follow-up will be compared to the score at baseline. | 30 days, 3 months, 6 months, and 12 months | 
| Esophageal stricture diameter | Endoscopy and esophagography will be conducted to measure the internal caliber of the esophagus. Results will be reported in millimeters. | 30 days, 3 months, 6 months, and 12 months | 
| Technical success | Successful delivery of the drug coated balloon to the target stricture, balloon inflation to the desired pressure, balloon deflation and withdraw without device malfunction. | Time of procedure |