Clinical trial · Interventional
Radial Reload Open LAR Case Series
Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
NCT01717014CI-TRIAL-00016957terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection | — | UNRESOLVED | — |
| Proctosigmoid Resection | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Covidien Radial Reload Stapler with Tri-Staple Technology | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Covidien Radial Reload Stapler with Tri-Staple Technology
- description
- Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
- interventionNames
- Device: Covidien Radial Reload Stapler with Tri-Staple Technology
Primary outcomes (2)
- measure
- Staple Line
- timeFrame
- Operative
- description
- The surgeons ability to achieve a staple line at the desired level of the rectum.
- measure
- Distal Margins
- timeFrame
- Operative
- description
- The ability to achieve adequate distal margins (defined as \>2cm \[or \>1cm with clear histologic evaluation\]) in the low rectum.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject is able to understand and sign Informed Consent Form. 2. The subject is between 18-85 years of age. 3. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer. 4. The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision. Exclusion Criteria: 1. Any female patient, who is pregnant, suspected pregnant, or nursing. 2. The participant is unable or unwilling to comply with the study requirements, follow-up schedule. 3. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.