POISE I Pilot Study | NCT03886324

Studies
POISE I Pilot Study

NCT03886324

Sponsor

GIE Medical

Status

Unknown status

Last Update Posted

Aug 17, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Intestinal Stricture

Interventions

GIE Medical Drug Coated Balloon

Countries

Paraguay

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2019Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 20, 2019

First Submission Date that Met QC Criteria

Mar 20, 2019

First Posted Date

Mar 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2022

Last Update Posted Date

Aug 17, 2022Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
DCB Treatment	Experimental	Stricture patients treated by DCB	Combination Product: GIE Medical Drug Coated Balloon

Name	Type	Description	Arm Group Labels	Other Names
GIE Medical Drug Coated Balloon	Combination Product	Stricture patients treated by DCB	DCB Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	30 days

Secondary Outcomes

Measure	Description	Time Frame
Procedure success	defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS).	6 months
Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided