COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
This study has been completed.
Sponsor:
novoGI
Collaborators:
Atlanta Colon & Rectal Surgery
FPMG Center for Colon & Rectal Surgery
Lester E. Cox Medical Centers
UCI Medical Center Irvine CA
NorthShore University HealthSystem Research Institute
St.Louis University hospital MO
University of Southern California
Bnai Zion Medical Center
Barmherzig Brueder
Catharina Ziekenhuis Eindhoven
Ziekenhuis Oost-Limburg
University Hospital, Gasthuisberg
Klinikum Neuperlach
Information provided by (Responsible Party):
novoGI
ClinicalTrials.gov Identifier:
NCT01091155
First received: March 19, 2010
Last updated: February 1, 2012
Last verified: February 2012
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Purpose
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Surgery |
Device: ColonRing (Colorectal anastomosis) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study |
Further study details as provided by novoGI:
Primary Outcome Measures:
- To evaluate rate of anastomotic leaks related to the use of the ColonRing™ device, at 1 month [ Time Frame: Approx. 1 year ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Rate of other device related complications and other parameters during hospitalization and post procedure. [ Time Frame: Approx. 1 year ] [ Designated as safety issue: Yes ]
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")
| Enrollment: | 279 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ColonRing TM |
Device: ColonRing (Colorectal anastomosis)
Creation of a colorectal compression anastomosis
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is ≥ 18 years old.
- BMI < 34.
- Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Exclusion Criteria:
- Subject has a known allergy to nickel.
- 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.
- Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
- Subject's ASA (American Society of Anesthesiology) score 4 or 5.
- Subject has a concurrent or previous invasive pelvic malignancy.
- Subject has a systemic or incapacitating disease.
- Subject has extensive local disease in the pelvis.
- Subject requires more than one anastomosis during the surgery.
- Women who are known to be pregnant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091155
Locations
| United States, California | |
| UCI Medical Center | |
| Irvine, California, United States | |
| University of Southern California Health Sciences Campus | |
| Los-Angeles, California, United States | |
| United States, Florida | |
| FPMG Center for Colon & Rectal Surgery | |
| Orlando, Florida, United States, 32804 | |
| United States, Georgia | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States | |
| United States, Illinois | |
| NorthShore University Health System | |
| Evanston, Illinois, United States | |
| United States, Missouri | |
| Lester E. Cox Medical Center | |
| Springfield, Missouri, United States | |
| St. Louis University Hospital | |
| St. Louis, Missouri, United States | |
| Austria | |
| KH Barmherzig Brueder | |
| Vienna, Austria, A-1020 | |
| Belgium | |
| Ziekenhuis Oost Limburg | |
| Genk, Belgium, 3600 | |
| University Hospital Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Germany | |
| Klinikum Neuperlach | |
| Munich, Germany, 81737 | |
| Israel | |
| Bnai Zion Medical Center | |
| Haifa, Israel, 31048 | |
| Netherlands | |
| Catharina Ziekenhuis | |
| Eindhoven, Netherlands, 5623EJ | |
Sponsors and Collaborators
novoGI
Atlanta Colon & Rectal Surgery
FPMG Center for Colon & Rectal Surgery
Lester E. Cox Medical Centers
UCI Medical Center Irvine CA
NorthShore University HealthSystem Research Institute
St.Louis University hospital MO
University of Southern California
Bnai Zion Medical Center
Barmherzig Brueder
Catharina Ziekenhuis Eindhoven
Ziekenhuis Oost-Limburg
University Hospital, Gasthuisberg
Klinikum Neuperlach
Investigators
| Study Director: | Yael Nir, M.D. | NiTi Surgical Solutions Ltd. |
More Information
Additional Information:
No publications provided
| Responsible Party: | novoGI |
| ClinicalTrials.gov Identifier: | NCT01091155 History of Changes |
| Obsolete Identifiers: | NCT00859924 |
| Other Study ID Numbers: | Protocol COMPRES 23/11/2009 |
| Study First Received: | March 19, 2010 |
| Last Updated: | February 1, 2012 |
| Health Authority: | Austria: Ethikkommission Belgium: Institutional Review Board Germany: Ethics Commission Netherlands: Independent Ethics Committee Israel: Ethics Commission United States: Institutional Review Board |
Keywords provided by novoGI:
|
Colon Anastomosis Rectum Anastomosis Intestine Colorectal Surgery Colorectal Anastomosis |
ClinicalTrials.gov processed this record on May 19, 2013