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Status unknownNCT03997994DIGESTUpdated Aug 17, 2022

DIGEST I Drug Coated Balloon for Biliary Stricture

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

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Biliary Stricture
  • Biliary Anastomotic Stenosis
  • Biliary Obstruction
  • Biliary Disease
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 and ≤ 80 years.
  2. Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
  3. 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).
  4. Greater than 40% stenosis of the biliary tract via ERCP.
  5. 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.
  6. Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
  7. Stricture length \<4 cm.
  8. Not currently listed for liver transplantation.
  9. Voluntary participation and provided written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
  2. Benign biliary strictures caused by pancreatic pseudocyst compression.
  3. Malignant biliary obstruction.
  4. Biliary obstruction associated with an attack of acute pancreatitis.
  5. Inability to pass guidewire across stricture.
  6. Subjects with cholangitis or bile leak or duct fistula.
  7. Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
  8. Subject with an internal/external biliary drainage catheter.
  9. Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
  10. Subject with symptomatic duodenal stenosis (with gastric stasis)
  11. Active systemic infection.
  12. Allergy to paclitaxel or any components of the delivery system.
  13. Currently undergoing required thoracic or abdominal cavity radiation therapy.
  14. Has life expectancy \<12 months.
  15. Unwilling or unable to comply with the follow-up study requirements.
  16. Lacking capacity to provide informed consent.
  17. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
  18. Currently participation in another pre-market drug or medical device clinical study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Experimental: DCB Treatment

    Stricture patients treated by DCB

    Device: GIE Drug Coated Balloon

Interventions

  • DeviceGIE Drug Coated Balloon

    The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.

05

What researchers measure

Primary outcomes

  1. 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

  2. Freedom from Biliary Stricture Re-intervention

    Biliary stricture re-intervention rate

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. 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

  3. Biliary Stricture Diameter

    Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)

    Time frame: Baseline, 6 months

  4. 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

  5. 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

  6. 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

  7. Mean number of dilations

    Mean number of dilations required to achieve SCS and LTCS

    Time frame: 12 months and 24 months

  8. 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

06

Study locations

1 site
  • Adventista Hospital
    Asunción, Paraguay
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03997994
Lead sponsor
GIE Medical
Responsible party
Sponsor
First posted
Jun 25, 2019
Start date
May 12, 2019
Primary completion
Mar 21, 2024 (estimated)
Completion
Mar 21, 2025 (estimated)
Last update
Aug 17, 2022

Study contacts

Bret T Petersen, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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