COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Colorectal Surgery Clinical Trial

— COMPRES  

Official title:

COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091155
• Other study ID #: Protocol COMPRES 23/11/2009
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2010
• Last updated: August 20, 2013
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2013
• Source: novoGI
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Institutional Review BoardGermany: Ethics CommissionNetherlands: Independent Ethics CommitteeIsrael: Ethics CommissionUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00859924

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Device:
• ColonRing (Colorectal anastomosis)
Creation of a colorectal compression anastomosis

Locations

Country	Name	City	State
Austria	KH Barmherzig Brueder	Vienna
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	University Hospital Gasthuisberg	Leuven
Germany	Klinikum Neuperlach	Munich
Israel	Bnai Zion Medical Center	Haifa
Netherlands	Catharina Ziekenhuis	Eindhoven
United States	NorthShore University Health System	Evanston	Illinois
United States	UCI Medical Center	Irvine	California
United States	University of Southern California Health Sciences Campus	Los-Angeles	California
United States	FPMG Center for Colon & Rectal Surgery	Orlando	Florida
United States	Southern Regional Medical Center	Riverdale	Georgia
United States	Lester E. Cox Medical Center	Springfield	Missouri
United States	St. Louis University Hospital	St. Louis	Missouri

Sponsors (14)

Lead Sponsor

Collaborator

novoGI

Atlanta Colon & Rectal Surgery, Atlanta, GA, Barmherzig Brueder, Bnai Zion Medical Center, Catharina Ziekenhuis Eindhoven, FPMG Center for Colon & Rectal Surgery, Klinikum Neuperlach, Lester E. Cox Medical Centers, NorthShore University HealthSystem Research Institute, St.Louis University hospital MO, UCI Medical Center Irvine CA, University Hospital, Gasthuisberg, University of Southern California, Ziekenhuis Oost-Limburg

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Germany,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month	Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.	Approx. 1 year	Yes
Primary	Device Related Leak Rate up to 30 Days Post op	Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.	30 days post op	Yes
Secondary	Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.	The post operative parameters that will be measured during hospitalization period: Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home; First day to first postoperative flatus; First day to first postoperative bowel movements; First day of first postoperative toleration of liquids and solids (time to "keeping them down")	30 days post op	Yes

External Links

•   Click here for more information about study device (sponsor's web site)