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INGEST I Pilot Study (INGEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885310
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
GIE Medical

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

Condition or disease Intervention/treatment Phase
Esophageal Stricture Device: GIE Drug Coated Balloon Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
Actual Study Start Date : February 24, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: DCB Treatment
Stricture patients treated by DCB
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Numbers of additional esophageal dilation procedures [ Time Frame: 30 days, 3 months, 6 months, and 12 months ]
    Repeat stricture treatments

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885310


Contacts
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Contact: Peter J Barnett, MS 763-219-8902 barnettp@giemedical.com

Locations
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Paraguay
Adventista Hospital Recruiting
Asunción, Paraguay
Contact: Carlos A Cetraro    0981 524 485    cetraroca@gmail.com   
Sponsors and Collaborators
GIE Medical
Investigators
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Principal Investigator: Kenneth Wang, MD Mayo Clinic
More Information
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Responsible Party: GIE Medical
ClinicalTrials.gov Identifier: NCT03885310    
Other Study ID Numbers: PR2001
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases