Recruiting

Compression Anastomosis

Sponsor:

novoGI

Code:

NCT01880918

Conditions

Diverticulum, Colon

Colorectal Neoplasms

Crohn Disease

Colitis, Ulcerative

Colostomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.

Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.

Conditions

Diverticulum, Colon

Colorectal Neoplasms

Crohn Disease

Colitis, Ulcerative

Colostomy

Study ID

NCT01880918

Start date

Oct, 2012

Status verified date

Jun, 2013

Completion date

Jul, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient was > 18 years old at time of procedure
2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
3. Patient treated in routine clinical practice
4. Patient underwent his/her first follow-up visit within two months post-surgery

Exclusion Criteria:

No exclusion criteria have been defined for this data collection.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

ColonRing

The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.

Primary outcome measure

  • The rate of anastomotic leakage. [ Time Frame: 6 weeks after the procedure ]

Central Contacts and Locations

Locations

Florida Hospital, Center for Colon & Rectal Surgery

Recruiting

Atlamonte Springs, Florida, United States, 32701

Contacts

Dr. Matthew Albert, MD

407-303-5191

Leslee Cunnion

407-303-5191Leslee.Cunnion@flhosp.org

Principal Investigator:

Dr. Matthew Albert, MD

18308 Murdock Circle, Suite 108

Recruiting

Port Charlotte, Florida, United States

Contacts

Dr. Domingo E. Galliano Jr., MD

941-625-3411office@gallianosurgery.com

Principal Investigator:

Dr. Domingo E. Galiano Jr., MD

CoxHealth Hospital, Colorectal Department

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Dr. Jose Dominguez, MD

417-875-3211

Kami Oster

417- 875-3211Kami.Oster@coxhealth.com

Principal Investigator:

Dr. Jose Dominguez, MD

More Information

Sponsor

novoGI

Last update posted

Jun 19, 2013

Last verified

Jun, 2013

Keywords

  • Compression Anastomosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by novoGI on 2013-06-19.