MedTrace Logo

Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™

NCT03462563 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2022-08-10

Study results available
· View outcomes & findings →

Summary

This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).

During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen). The subjects will return 3-9 months after the phase 1 operation (colorectal resection with temporary ileostomy) for phase 2 operation, to have their diverting ostomy taken down (ileostomy reversal). During the phase 2 operation (ileostomy reversal), the incidence, extent and severity of adhesions will be evaluated through the laparoscope.

Conditions

  • Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy

Interventions

DEVICE

INTERCEED™

when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen)

DEVICE

Placebo

During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo).

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2021-02-24
Completion
2021-02-24

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462563 on ClinicalTrials.gov