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NCT01301417 · ClinicalTrials.gov registry record
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
A clinical trial, sponsored by novoGI.
- Completed
- Registry status
- 171
- Enrollment target
NCT01301417: Completed study, sponsored by novoGI.
NCT01301417 is a clinical trial that has completed, run by novoGI. The registered enrollment target is 171 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01301417 has completed, sponsored by novoGI.
- COMPLETED
- Registry status
- 171 participants
- Enrollment target
Study 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 a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. 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.
Primary Outcome
The primary study outcome is the rate of anastomotic leakage. Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
Interventions
- DEVICE ColonRing™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-08 |
What the finished NCT01301417 record still lists
NCT01301417 is an observational study that tracks outcomes without assigning an intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which ColonRing™ is the first listed.
NCT01301417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01301417 about?
NCT01301417 is a clinical study titled "Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis". 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 a single center. The data will assist in further evaluating the performance of the ColonRing™ device ...
What is the current status of trial NCT01301417?
This trial is currently completed. The enrollment target is 171 participants. The study started on 2011-02. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01301417?
The interventions under investigation include: ColonRing™ (DEVICE).
Who is sponsoring clinical trial NCT01301417?
This trial is sponsored by novoGI, which has 2 total clinical trials registered on ClinicalTrials.gov.
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