POISE I Pilot Study

NCT03886324 | Unknown

• 1 other identifier: PR2002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.

Conditions

Intestinal Stricture

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• Procedure success

  6 months

• Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)

  6 months

• Change in obstructive symptoms using the Obstructive Symptom Score (OSS).

  30 days, 3 months, 6 months, and 12 months

• Number of repeated stricture dilation procedures

  30 days, 3 months, 6 months, and 12 months

• Procedural technical success

  Time of procedure

Study Arms (1)

DCB Treatment

EXPERIMENTAL

Stricture patients treated by DCB

Combination Product: GIE Medical Drug Coated Balloon

Interventions

GIE Medical Drug Coated Balloon COMBINATION_PRODUCT

Stricture patients treated by DCB

DCB Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GIE Medical: lead

Study Sites (1)

Adventista Hospital

Asunción, Paraguay

Location

Study Officials

• Bo Shen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: February 25, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

PA (1)