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

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2011-005479-17-BE
• Date of registration: 11/04/2012
• Prospective Registration: Yes
• Primary sponsor: Ethicon Inc., a Johnson & Johnson Co.
• Public title: A study of the safety and effectiveness of EVICEL® as a treatment in addition to standard techniques of joining the colon together
• Scientific title: A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques - The EVICEL® GI Study
• Date of first enrolment: 25/05/2012
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005479-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Standard of care Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Korea, Republic of, New Zealand, United Kingdom, United States

Contacts

• Name: Assoc. Dir., Clinical Development
• Affiliation: Ethicon Inc., a Johnson & Johnson Co.

• Name: Assoc. Dir., Clinical Development
• Affiliation: Ethicon Inc., a Johnson & Johnson Co.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Gastrointestinal Anastomosis Leak

Intervention(s)

Trade Name: EVICEL®
Product Name: EVICEL®
Pharmaceutical Form: Sealant
INN or Proposed INN: Human Thrombin
CAS Number: 9002-04-4
Other descriptive name: Thrombin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 800-1200
INN or Proposed INN: HUMAN FIBRINOGEN
CAS Number: 9001-32-5
Other descriptive name: BAC 2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 50-90

Primary Outcome(s)

Secondary Objective: - Incidence of adverse events up to post operative Day 90;
- Incidence of clinical anastomotic leak within 90 days post operatively;
- Incidence of stricture (up to post operative Day 90);
- Incidence of post operative intervention related to clinical anastomotic leak or stricture (percutanous drainage, intraluminal stenting or reoperation), up to post operative Day 90.

Main Objective: To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to stapled anastomosis after lower anterior resection (LAR).

This will be done by assessing the absence of clinical anastomotic leak (success) within 40 days post operatively.

Clinical anastomotic leak is defined as signs and symptoms that are confirmed by one or more of the following methods:
• Confirmation on imaging;
• Visual confirmation (eg., reoperation/drain output).

Primary end point(s): The proportion of subjects with absence of clinical anastomotic leak within 40 days post-operatively.

Timepoint(s) of evaluation of this end point: Within 40 days post-operatively.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 76 -104 days post-operatively.

Secondary end point(s): - Incidence of adverse events up to post operative Day 90;
- Incidence of clinical anastomotic leak within 90 days post operatively;
- Incidence of stricture (up to post operative Day 90);
- Incidence of post operative intervention related to clinical anastomotic leak or stricture (percutanous drainage, intraluminal stenting or reoperation), up to post operative Day 90.

Secondary ID(s)

2011-005479-17-GB

400-11-002

Source(s) of Monetary Support

Ethicon