An interventional study of GIE Drug Coated Balloon in Biliary Stricture, Biliary Anastomotic Stenosis and Biliary Obstruction, 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 2022-08-17.
Sponsored by GIE Medical · Not applicable, Interventional, and Treatment
DIGEST 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 biliary tract stricture.
Up to 15 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.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases 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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 coated with a proprietary coating containing the drug and carriers.
Incident of serious balloon dilation-related complications
No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.
Time frame: 30 days
Freedom from Biliary Stricture Re-intervention
Biliary stricture re-intervention rate
Time frame: 12 months
Change in Liver Function
. Liver function tests include total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)
Time frame: Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months
Change in Existing Biliary Obstructive Symptoms
The common biliary obstructive symptoms are right upper quadrant pain (survey), fever/chills (cholangitis), jaundice, itching, dark urine, pale stools, nausea/vomiting, weight loss
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Biliary Stricture Diameter
Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)
Time frame: Baseline, 6 months
Time to the First Re-intervention
The mean time to the first re-intervention (scheduled and unscheduled) will be assessed
Time frame: 12 months and 24 months
Sustained Clinical Success (SCS)
SCS defined as a period of at least 6 months with no need for further endoscopic intervention
Time frame: 12 months and 24 months
Long Term Clinical Success (LTCS)
LTCS, defined as no need for further endoscopic intervention for at least 24 months
Time frame: 12 months and 24 months
Mean number of dilations
Mean number of dilations required to achieve SCS and LTCS
Time frame: 12 months and 24 months
Technical Success
Technical success is defined as successful insertion, dilatation of the target biliary stricture, and finally withdrawal of the device with no device malfunctions.
Time frame: 0 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2019 (actual). Primary completion is estimated for Mar 2024, 58 months after the start.
Of 34 interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 26. This study's planned 58 months is above that.
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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