Back to resultsPOISE I Pilot Study (POISE)
Primary Purpose
Intestinal Stricture
Status
Active
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
GIE Medical Drug Coated Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Stricture
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 80 years.
- Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture.
- Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs.
- Symptoms of intestinal partial occlusion
- Length of stenosis/stricture ≤ 7 cm
- Up to 2 discrete strictures.
- Ability to undergo periodic endoscopic follow-up.
- Voluntary participation and provided written informed consent.
Exclusion Criteria:
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Contraindication to endoscopy, anesthesia or deep sedation.
- Malignant bowel stricture.
- Extrinsic benign bowel stricture due to adhesion.
- Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis
- More than 2 stenosis/stricture lesions.
- Length of stenosis/stricture > 7 cm.
- Stricture not accessible by endoscopy.
- Suspected perforation of the gastrointestinal tract
- Acute bowel obstruction requiring urgent surgical intervention
- Low rectal or anal strictures
- Severe coagulation disorders (platelets < 70000; INR > 1.8).
- Active systemic infection
- Allergy to paclitaxel or any components of the delivery system.
- Life expectancy of less than 12 months.
- Drug abuse or on chronic steroid therapy for comorbidities.
- 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.
- Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
- Currently requiring abdominal radiation therapy
Sites / Locations
- Adventista Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCB Treatment
Arm Description
Stricture patients treated by DCB
Outcomes
Primary Outcome Measures
Incident of serious balloon dilation-related complications
Perforation, bleeding requiring endoscopic or surgical interventions or blood transfusion, severe abdominal pain requiring medications, infection requiring hospitalization or IV antibiotics
Secondary Outcome Measures
Procedure success
defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS).
Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)
Analyzed by 1, 2, or 3 scale improvement.
Change in obstructive symptoms using the Obstructive Symptom Score (OSS).
The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (1=no pain, 2=mild, 3=moderate, 4=severe, 5=unbearable).
Number of repeated stricture dilation procedures
Repeat dilation for stricture recurrence
Procedural technical success
Successful endoscopic passage followed by successful delivery of the drug-coated balloon to the stricture area without resistance, inflated balloon to the defined diameter, DCB withdraw after deflating balloon without device malfunction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03886324
Brief Title
POISE I Pilot Study
Acronym
POISE
Official Title
Paclitaxel-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Intestinal Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GIE Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.
Detailed Description
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB) for treating intestinal strictures.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Stricture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCB Treatment
Arm Type
Experimental
Arm Description
Stricture patients treated by DCB
Intervention Type
Combination Product
Intervention Name(s)
GIE Medical Drug Coated Balloon
Intervention Description
Stricture patients treated by DCB
Primary Outcome Measure Information:
Title
Incident of serious balloon dilation-related complications
Description
Perforation, bleeding requiring endoscopic or surgical interventions or blood transfusion, severe abdominal pain requiring medications, infection requiring hospitalization or IV antibiotics
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedure success
Description
defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS).
Time Frame
6 months
Title
Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)
Description
Analyzed by 1, 2, or 3 scale improvement.
Time Frame
6 months
Title
Change in obstructive symptoms using the Obstructive Symptom Score (OSS).
Description
The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (1=no pain, 2=mild, 3=moderate, 4=severe, 5=unbearable).
Time Frame
30 days, 3 months, 6 months, and 12 months
Title
Number of repeated stricture dilation procedures
Description
Repeat dilation for stricture recurrence
Time Frame
30 days, 3 months, 6 months, and 12 months
Title
Procedural technical success
Description
Successful endoscopic passage followed by successful delivery of the drug-coated balloon to the stricture area without resistance, inflated balloon to the defined diameter, DCB withdraw after deflating balloon without device malfunction.
Time Frame
Time of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 and ≤ 80 years.
Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture.
Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs.
Symptoms of intestinal partial occlusion
Length of stenosis/stricture ≤ 7 cm
Up to 2 discrete strictures.
Ability to undergo periodic endoscopic follow-up.
Voluntary participation and provided written informed consent.
Exclusion Criteria:
Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
Contraindication to endoscopy, anesthesia or deep sedation.
Malignant bowel stricture.
Extrinsic benign bowel stricture due to adhesion.
Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis
More than 2 stenosis/stricture lesions.
Length of stenosis/stricture > 7 cm.
Stricture not accessible by endoscopy.
Suspected perforation of the gastrointestinal tract
Acute bowel obstruction requiring urgent surgical intervention
Low rectal or anal strictures
Severe coagulation disorders (platelets < 70000; INR > 1.8).
Active systemic infection
Allergy to paclitaxel or any components of the delivery system.
Life expectancy of less than 12 months.
Drug abuse or on chronic steroid therapy for comorbidities.
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.
Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
Currently requiring abdominal radiation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Shen, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adventista Hospital
City
Asunción
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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POISE I Pilot Study
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