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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005479-17-GB

Enrollment

150

Registered

2012-04-03

Start date

2012-05-02

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Anastomosis Leak

Interventions

Trade Name: EVICEL® Product Name: EVICEL® Pharmaceutical Form: Sealant INN or Proposed INN: Human Thrombin CAS Number: 9002-04-4

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: Preoperative: 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. Intraoperative: 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 hemostasis during the surgical procedure.

Design outcomes

Primary

Measure	Time frame
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.; 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). ; 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.	—

Measure

Time frame

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.; 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). ; 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.

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Secondary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: 76 -104 days post-operatively.	—

Measure

Time frame

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

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Countries

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

Contacts

Public ContactAssoc. Dir., Clinical Development

Ethicon Inc., a Johnson & Johnson Co.

jbatill2@its.jnj.com12089182492

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026