An interventional study of GIE Drug Coated Balloon in Esophageal Stricture, sponsored by GIE Medical. Status unknown at 1 site in Paraguay. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by GIE Medical · Not applicable, Interventional, and Treatment
INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
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.
47 studies on the registry are indexed under Esophageal Stenosis; 13 are open to participants now.
This study's enrollment of 9 is below the median of 30 across 36 interventional studies indexed under Esophageal Stenosis.
Browse Esophageal Stenosis studies →GIE Medical is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Numbers of additional esophageal dilation procedures
Repeat stricture treatments
Time frame: 30 days, 3 months, 6 months, and 12 months
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.
Time frame: 30 days, 3 months, 6 months, and 12 months
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.
Time frame: 30 days, 3 months, 6 months, and 12 months
Esophageal stricture diameter
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
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.
Time frame: Time of procedure
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2019 (actual). Primary completion is estimated for Dec 2024, 70 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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