Clinical trial · Observational
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis, Ulcerative | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colostomy | — | UNRESOLVED | — |
| Crohn Disease | — | UNRESOLVED | — |
| Diverticulum, Colon | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Ileostomy - Stoma | — | UNRESOLVED | — |
| Intestinal Polyposis | — | UNRESOLVED | — |
| Intestinal Volvulus | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Rectal Prolapse | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ColonRing™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ColonRing™
- description
- Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice
- interventionNames
- Device: ColonRing™
Primary outcomes (1)
- measure
- Rate of anastomotic leakage
- timeFrame
- 2-mo post-op
- description
- 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.
Secondary outcomes (1)
- measure
- Rate of other device related complications and measures during hospitalization and post procedure:
- timeFrame
- 2-mo post-op
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient was \> 18 years old at time of procedure * Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™ * Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use * 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.
References
Publications (0)
Data not yet available