Clinical trial · Interventional
Radial Reload Laparoscopic LAR Case Series
Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Laparoscopic Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
NCT01706822CI-TRIAL-00017170terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
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 laparoscopic LAR or proctosigmoidectomy
- interventionNames
- Device: Covidien Radial Reload Stapler with Tri-Staple Technology
Primary outcomes (2)
- measure
- The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
- timeFrame
- Operative
- description
- The surgeon's ability to achieve a staple line at the desired level of the rectum.
- measure
- The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
- timeFrame
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. 4. The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically. 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.