INGEST I Pilot Study (INGEST)

August 9, 2022 updated by: GIE Medical

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

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

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Asunción, Paraguay
        • Adventista Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCB Treatment
Stricture patients treated by DCB
The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of additional esophageal dilation procedures
Time Frame: 30 days, 3 months, 6 months, and 12 months
Repeat stricture treatments
30 days, 3 months, 6 months, and 12 months
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.
30 days, 3 months, 6 months, and 12 months
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.
30 days, 3 months, 6 months, and 12 months
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.
30 days, 3 months, 6 months, and 12 months
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.
Time of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Kenneth Wang, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2019

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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