INGEST I Pilot Study

Overview

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

Full Title of Study: “Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Device: GIE Drug Coated Balloon
    • The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.

Arms, Groups and Cohorts

  • Experimental: DCB Treatment
    • Stricture patients treated by DCB

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Numbers of additional esophageal dilation procedures
    • Time Frame: 30 days, 3 months, 6 months, and 12 months
    • Repeat stricture treatments
  • Time to first dysphagia symptom recurrence
    • Time Frame: 30 days, 3 months, 6 months, and 12 months
    • 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.
  • Improvement in dysphagia score
    • Time Frame: 30 days, 3 months, 6 months, and 12 months
    • 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.
  • Esophageal stricture diameter
    • Time Frame: 30 days, 3 months, 6 months, and 12 months
    • Endoscopy and esophagography will be conducted to measure the internal caliber of the esophagus. Results will be reported in millimeters.
  • Technical success
    • Time Frame: Time of procedure
    • Successful delivery of the drug coated balloon to the target stricture, balloon inflation to the desired pressure, balloon deflation and withdraw without device malfunction.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GIE Medical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kenneth Wang, MD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Peter J Barnett, MS, 763-219-8902, barnettp@giemedical.com

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