A study of the safety and effectiveness of EVICEL® as a treatment in addition to standard techniques of joining the colon together

Phase 1

• Conditions: Gastrointestinal Anastomosis Leak; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2011-005479-17-BE
• Lead Sponsor: Ethicon Inc., a Johnson & Johnson Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-11
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Preoperative:
1) Subjects undergoing primary elective lower anterior resection with a stapled end-to-end or end-to-side anastomosis;
2) Subjects = 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures;
Intraoperative:
3) Confirmed distance of anastomosis is =12cm from the anal verge, as measured using a rigid scope or non-flexible scope alternative.
4) Anastomosis with a successful leak test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Pre-operative:
1) Avastin use within 30 days prior to surgery;
2) Known hypersensitivity to the human blood products or the components of the investigational product;
3) Female subjects who are pregnant or nursing;
4) Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.

Intra-operative:
5) Subject requiring protective ostomy;
6) Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures.
7) Use of any fibrin sealant for haemostasis during the surgical procedure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified