Colonic Obstruction, Colonic Stricture, Large Bowel Obstruction
Conditions
Keywords
Colonic obstruction
Brief summary
The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
Interventions
DEVICEEvolution(R) Colonic Stent
Palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
Sponsors
Cook Group Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: per the IFU, * colonic strictures caused by malignant neoplasms, and * large bowel obstruction due to malignant strictures prior to colectomy. Exclusion: * central ischemia, * any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement, * suspected or impending perforation, * intra-abdominal abscess/perforation, * inability to pass wire guide or stent deployment system through the obstructed area, * patients for whom endoscopic or percutaneous procedures are contraindicated, * benign disease, and * coagulopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief of obstruction | At the Conclusion of the Procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Duration | 6 months | — |
| Symptoms at Follow-up | 6 months | — |
| Complications | 6 months | perforation, migration, obstruction, GI bleeding requiring intervention |
Countries
Canada, Denmark, France, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed