INGEST I Pilot Study (INGEST)
|ClinicalTrials.gov Identifier: NCT03885310|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Stricture||Device: GIE Drug Coated Balloon||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885310
|Contact: Peter J Barnett, MSfirstname.lastname@example.org|
|Contact: Carlos A Cetraro 0981 524 485 email@example.com|
|Principal Investigator:||Kenneth Wang, MD||Mayo Clinic|