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

NCT03462563 | Terminated Phase 3 Results

• 1 other identifier: ESC-201701
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Free of Adhesions at the Target Incision Site

  Percentage of participants free of adhesions at the target incision site in each study group based on evaluation through laparoscopy at ileostomy reversal were reported.

  3 to 9 months after phase 1 operation

Secondary Outcomes (5)

• Number of Participants With Extent of Adhesions at Target Incision Site in Phase 2 Operation

  3 to 6 months after phase 1 operation

• Number of Participants With Severity of Adhesions at Target Incision Site in Phase 2 Operation

  3 to 9 months after phase 1 operation

• Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation

  3 to 9 months after phase 1 operation

• Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation

  3 to 6 months after phase 1 operation

• Number of Participants With Mechanical Ileus

  Up to 9 months after phase 1 operation

Study Arms (2)

INTERCEED™

EXPERIMENTAL

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: INTERCEED™

standard of care treatment

PLACEBO COMPARATOR

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).

Device: Placebo

Interventions

INTERCEED™ DEVICE

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)

INTERCEED™

Placebo DEVICE

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).

standard of care treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects elder than 18 years of age who require laparoscopic colorectal resection with the formation of a temporary diverting loop ileostomy and a planned closure of diverting ileostomy within 3 to 7 months The subjects should be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent prior to any study-related procedures The target incision length less than 8cm allowing the INTERCEED (product length 10.2cm) to overlap at least 1cm beyond each pole of the incision The subject is believed to have life expectancy more than 12 months after Phase 1 operation, based on investigators assessment.

You may not qualify if:

• Bevacizumab use within 30 days prior to surgery Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures Patients with evidence of distant metastasis of the primary colorectal cancer Patients who underwent abdominal radiotherapy before Phase 1 operation Adhesions (Grade 2-3 adhesion) and/or gross contamination (caused by tumor perforation) present in the abdominal cavity at the Phase 1 operation The rectal carcinoma radical resection (R0 resection) preventive ileostomy are not performed in Phase 1 operation pected resection of other organs (bladder, uterus) during Phase 1 operation Use of topical haemostatic products, local motherapeutic products or other drugs and/or medical device in abdominal/pelvic cavity which may impact the study primary endpoint judged by the investigator Patient is participating in other investigational drug or device study within 30 days or 5 half-lives of an investigational drug A known history of severe multiple drug allergies or known allergy to cellulose or cellulose derived products Any medications, treatments and/or implanted devices (except INTERCEED) that on investigator's opinion may be adhesiogenic or may potentially affect the observation of postoperative adhesions Any physical or psychological conditions that at discretion of investigators may impair study participation A medical condition or other serious conditions that will interfere with compliance and/or ability to complete this study protocol; or Any other situation or reason that at discretion of investigators is unsuitable for study participation

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (12)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

First affiliated hospital of zhengzhou university

Zhengzhou, Henan, 450052, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

The 2nd affiliated Hospital of Zhongnan University

Changsha, Hunan, 410011, China

Location

The affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shanghai Jiaotong University School of Medcine, Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Chinese PLA General Hospital

Beijing, 100039, China

Location

Friendship Hospital

Beijing, 100050, China

Location

Changhai Hospital

Shanghai, 200433, China

Location

Limitations and Caveats

The study was terminated due to small effect size between INTERCEED and control arms.

Results Point of Contact

• Title: Richard Kocharian
• Organization: Ethicon SARL

rkochar1@its.jnj.com

+1 609 6423787

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: April 16, 2018
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: August 10, 2022
• Results First Posted: May 13, 2022

Record last verified: 2022-08

Locations

CN (12)