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DIGEST I Pilot Study (DIGEST) (DIGEST)

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ClinicalTrials.gov Identifier: NCT03997994
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
GIE Medical

Brief Summary:
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

Condition or disease Intervention/treatment Phase
Biliary Stricture Biliary Anastomotic Stenosis Biliary Obstruction Biliary Disease Device: GIE Drug Coated Balloon Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture
Actual Study Start Date : May 12, 2019
Estimated Primary Completion Date : March 21, 2021
Estimated Study Completion Date : March 21, 2025

Arm Intervention/treatment
Experimental: Experimental: DCB Treatment
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.




Primary Outcome Measures :
  1. 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.

  2. Freedom from Biliary Stricture Re-intervention [ Time Frame: 12 months ]
    Biliary stricture re-intervention rate


Secondary Outcome Measures :
  1. Change in Liver Function [ Time Frame: 7 days, 30 days, 3 months, 6 months, 12 months and 24 months ]
    . Liver function tests include total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)

  2. Change in Existing Biliary Obstructive Symptoms [ Time Frame: 30 days, 3 months, 6 months, 12 months and 24 months ]
    The common biliary obstructive symptoms are right upper quadrant pain (survey), fever/chills (cholangitis), jaundice, itching, dark urine, pale stools, nausea/vomiting, weight loss

  3. Biliary Stricture Diameter [ Time Frame: 6 months ]
    Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)

  4. Time to the First Re-intervention [ Time Frame: 12 months and 24 months ]
    The mean time to the first re-intervention (scheduled and unscheduled) will be assessed

  5. Sustained Clinical Success (SCS) [ Time Frame: 12 months and 24 months ]
    SCS defined as a period of at least 6 months with no need for further endoscopic intervention

  6. Long Term Clinical Success (LTCS) [ Time Frame: 12 months and 24 months ]
    LTCS, defined as no need for further endoscopic intervention for at least 24 months

  7. Mean number of dilations [ Time Frame: 12 months and 24 months ]
    Mean number of dilations required to achieve SCS and LTCS

  8. Technical Success [ Time Frame: 0 months ]
    Technical success is defined as successful insertion, dilatation of the target biliary stricture, and finally withdrawal of the device with no device malfunctions.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997994


Contacts
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Contact: Peter J Barnett, MS 651-348-6329 barnettp@giemedical.com

Locations
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Paraguay
Adventista Hospital Recruiting
Asunción, Paraguay
Contact: Carlos A Cetraro    0981 524 485    cetraroca@gmail.com   
Sponsors and Collaborators
GIE Medical
Investigators
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Principal Investigator: Bret T Petersen, MD Mayo Clinic

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Responsible Party: GIE Medical
ClinicalTrials.gov Identifier: NCT03997994     History of Changes
Other Study ID Numbers: PR 2002
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gallbladder Diseases
Constriction, Pathologic
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases