Back to resultsINGEST I Pilot Study (INGEST)
Primary Purpose
Esophageal Stricture
Status
Active
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
GIE Drug Coated Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Stricture
Eligibility Criteria
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.
Sites / Locations
- Adventista Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCB Treatment
Arm Description
Stricture patients treated by DCB
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Numbers of additional esophageal dilation procedures
Repeat stricture treatments
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.
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.
Esophageal stricture diameter
Endoscopy and esophagography will be conducted to measure the internal caliber of the esophagus. Results will be reported in millimeters.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03885310
Brief Title
INGEST I Pilot Study
Acronym
INGEST
Official Title
Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 24, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GIE Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stricture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCB Treatment
Arm Type
Experimental
Arm Description
Stricture patients treated by DCB
Intervention Type
Device
Intervention Name(s)
GIE Drug Coated Balloon
Intervention Description
The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.
Primary Outcome Measure Information:
Title
Incident of serious balloon dilation-related complications
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Numbers of additional esophageal dilation procedures
Description
Repeat stricture treatments
Time Frame
30 days, 3 months, 6 months, and 12 months
Title
Time to first dysphagia symptom recurrence
Description
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.
Time Frame
30 days, 3 months, 6 months, and 12 months
Title
Improvement in dysphagia score
Description
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.
Time Frame
30 days, 3 months, 6 months, and 12 months
Title
Esophageal stricture diameter
Description
Endoscopy and esophagography will be conducted to measure the internal caliber of the esophagus. Results will be reported in millimeters.
Time Frame
30 days, 3 months, 6 months, and 12 months
Title
Technical success
Description
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 Frame
Time of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Wang, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adventista Hospital
City
Asunción
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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INGEST I Pilot Study
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