Trials / Unknown
UnknownNCT01880918
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- novoGI · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Ileostomy - Stoma
- Rectal Prolapse
- Intestinal Polyposis
- Lymphoma
- Endometriosis
- Intestinal Volvulus
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-06-01
- Completion
- 2013-07-01
- First posted
- 2013-06-19
- Last updated
- 2013-06-19
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01880918. Inclusion in this directory is not an endorsement.