Clinical trial NCT01091155: COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
Official title: COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Surgery
Keywords: Colon Anastomosis
Rectum Anastomosis
Intestine
Colorectal Surgery
Colorectal Anastomosis
Lead sponsor: novoGI
Sponsor class: INDUSTRY
Collaborators: name: Atlanta Colon & Rectal Surgery, Atlanta, GA
name: FPMG Center for Colon & Rectal Surgery
name: Lester E. Cox Medical Centers
name: UCI Medical Center Irvine CA
name: Endeavor Health
name: St.Louis University hospital MO
name: University of Southern California
name: Bnai Zion Medical Center
name: Barmherzig Brueder
name: Catharina Ziekenhuis Eindhoven
name: Ziekenhuis Oost-Limburg
name: University Hospital, Gasthuisberg
name: Klinikum Neuperlach
First posted: 2010-03-23
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

Detailed description: The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. BMI \< 34.
3. Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
4. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Subject has a known allergy to nickel.
2. Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis.
3. Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
4. Subject's ASA (American Society of Anesthesiology) score 4 or 5.
5. Subject has a concurrent or previous invasive pelvic malignancy.
6. Subject has a systemic or incapacitating disease.
7. Subject has extensive local disease in the pelvis.
8. Subject requires more than one anastomosis during the surgery.
9. Women who are known to be pregnant.

Primary outcomes:
measure: To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month
timeFrame: Approx. 1 year
measure: Device Related Leak Rate up to 30 Days Post op
timeFrame: 30 days post op
Secondary outcomes:
measure: Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.
timeFrame: 30 days post op
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Medical Center
state: California
city: Los-Angeles
country: United States
facility: University of Southern California Health Sciences Campus
state: California
city: Orlando
country: United States
facility: FPMG Center for Colon & Rectal Surgery
state: Florida
city: Riverdale
country: United States
facility: Southern Regional Medical Center
state: Georgia
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Springfield
country: United States
facility: Lester E. Cox Medical Center
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Vienna
country: Austria
facility: KH Barmherzig Brueder
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Munich
country: Germany
facility: Klinikum Neuperlach
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
affiliation: novoGI
name: Eran Choman, Msc
role: STUDY_DIRECTOR
References: