Biliary StrictureDIGESTNCT03997994
DIGEST I Drug Coated Balloon for Biliary Stricture
A study testing GIE Drug Coated Balloon in people with Biliary Stricture and Biliary Anastomotic Stenosis, run by GIE Medical at 1 site in Paraguay.
Trial summary
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction
- What is being tested?
- GIE Drug Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteParaguay
- Study dates
- 12 May 2019to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years.
- Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
- Restenosis after plain balloon dilation with at least 2 previous balloon dilation sessions and recurrence of biliary obstructive symptoms/signs or being managed with implantable prosthetics (e.g. plastic stents).
- Greater than 40% stenosis of the biliary tract via ERCP.
- Total serum bilirubin >2 mg/dL. Alkaline phosphatase level >3 times higher than normal level. *Note: This IC is waved if the patient is being managed with implantable prosthetics.
- Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
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- Stricture length <4 cm.
- Not currently listed for liver transplantation.
- Voluntary participation and provided written informed consent.
Who cannot join
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Benign biliary strictures caused by pancreatic pseudocyst compression.
- Malignant biliary obstruction.
- Biliary obstruction associated with an attack of acute pancreatitis.
- Inability to pass guidewire across stricture.
- Subjects with cholangitis or bile leak or duct fistula.
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- Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
- Subject with an internal/external biliary drainage catheter.
- Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
- Subject with symptomatic duodenal stenosis (with gastric stasis)
- Active systemic infection.
- Allergy to paclitaxel or any components of the delivery system.
- Currently undergoing required thoracic or abdominal cavity radiation therapy.
- Has life expectancy <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.
- Currently participation in another pre-market drug or medical device clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
Read the detailed description
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.
- Being tested
- GIE Drug Coated Balloon
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIE Drug Coated BalloonDevice
The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: DCB Treatment | Experimental | Stricture patients treated by DCB Receives: Device: GIE Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of serious balloon dilation-related complications
No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.
Measured: 30 days
Freedom from Biliary Stricture Re-intervention
Biliary stricture re-intervention rate
Measured: 12 months
Secondary outcomes (8)
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)
Measured: 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
Measured: 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)
Measured: Baseline, 6 months
Time to the First Re-intervention
The mean time to the first re-intervention (scheduled and unscheduled) will be assessed
Measured: 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
Measured: 12 months and 24 months
Long Term Clinical Success (LTCS)
LTCS, defined as no need for further endoscopic intervention for at least 24 months
Measured: 12 months and 24 months
Mean number of dilations
Mean number of dilations required to achieve SCS and LTCS
Measured: 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.
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start12 May 2019
- Primary completion21 Mar 2024 (estimated)
- Study completion21 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- GIE Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bret T Petersen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997994
- Sponsor's protocol ID
- PR 2002
- Acronym
- DIGEST
- Status last verified
- Aug 2022
- First submitted
- 21 Jun 2019
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture
- ClinicalTrials.gov ID
- NCT03997994
- Acronym / sponsor ID
- DIGEST / PR 2002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GIE MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 May 2019 (actual)
- Primary completion
- 21 Mar 2024 (estimated)
- Study completion
- 21 Mar 2025 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DIGEST 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: DCB Treatment | Experimental | Device: GIE Drug Coated BalloonStricture patients treated by DCB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 and ≤ 80 years.
- Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
- Restenosis after plain balloon dilation with at least 2 previous balloon dilation sessions and recurrence of biliary obstructive symptoms/signs or being managed with implantable prosthetics (e.g. plastic stents).
- Greater than 40% stenosis of the biliary tract via ERCP.
- Total serum bilirubin >2 mg/dL. Alkaline phosphatase level >3 times higher than normal level. *Note: This IC is waved if the patient is being managed with implantable prosthetics.
Key exclusion criteria (18 listed)
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Benign biliary strictures caused by pancreatic pseudocyst compression.
- Malignant biliary obstruction.
- Biliary obstruction associated with an attack of acute pancreatitis.
- Inability to pass guidewire across stricture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIE Drug Coated BalloonThe GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers. | Device | Experimental: DCB Treatment |
Primary outcome
Incident of serious balloon dilation-related complications
Time frame: 30 days
No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.
Freedom from Biliary Stricture Re-intervention
Time frame: 12 months
Biliary stricture re-intervention rate
8 secondary outcomes
Change in Liver Function
Time frame: Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months
Change in Existing Biliary Obstructive Symptoms
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Biliary Stricture Diameter
Time frame: Baseline, 6 months
Time to the First Re-intervention
Time frame: 12 months and 24 months
Sustained Clinical Success (SCS)
Time frame: 12 months and 24 months
Long Term Clinical Success (LTCS)
Time frame: 12 months and 24 months
Mean number of dilations
Time frame: 12 months and 24 months
Technical Success
Time frame: 0 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret T Petersen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIE Drug Coated Balloon in people with Biliary Stricture and Biliary Anastomotic Stenosis, run by GIE Medical at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of serious balloon dilation-related complications (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.