Clinical trial · Observational
A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures
NCT04247958CI-TRIAL-00072749completedClinicalTrials.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 primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
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 |
|---|---|---|---|
| Benign Colon Tumor | Benign Colon Neoplasm | ALIAS | 0.90 |
| Benign Colorectal Neoplasm | Benign Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Colorectal Tumor | Malignant Colorectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colorectal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Robotic-assisted colorectal resection
- description
- Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum.
- interventionNames
- Procedure: Colorectal resection
Primary outcomes (1)
- measure
- Number of SureForm™ Stapler fires and reload colors
- timeFrame
- During the procedure
- description
- The primary endpoint of the study is to assess the number of fires and reload colors of SureForm™ Staplers utilized for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
Secondary outcomes (1)
- measure
- Incidence of peri-operative and short term outcomes
- timeFrame
- 30 days post-operative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject must be 18 years of age or older at the time of consent * Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureForm™Staplers are utilized for transection and/or creation of anastomosis Exclusion Criteria: * Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy * Subject with active bacterial or fungal infection * Subject is contraindicated for general anesthesia or surgery * Subject is undergoing an emergency procedure * Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure. * Subject has metastatic disease and/or subject has life expectancy of less than 1 year * Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgical procedure * Subject has history of coagulation or hematologic disorder * Pregnant or suspect pregnancy * The subject is unable to comply with the follow-up visit schedule * Subject has perforated, obstructing or locally invasive neoplasm (T4b) * Subject with inflammatory bowel disease * Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent * Subject belonging to other vulnerable population, e.g, prisoner or ward of the state Intra-Operative Exclusion Criteria: * Subjects who require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler. * Inadequate visualization making an endoscopic approach not feasible * Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
References
Publications (0)
Data not yet available
No reference posted for this study.