Clinical trial · Observational
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy
Assessing the Safety and Performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy: a Monocentric Post-market Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Design modification
Summary
Brief summary (as posted)
The purpose of this observational study is to evaluate the safety and performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the ascending colon. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Linear Cutter Stapler and Reloads (Frankenman) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colon cancer patients
- description
- Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
- interventionNames
- Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)
Primary outcomes (3)
- measure
- Number of patients with adverse events related to the index-procedure.
- timeFrame
- 3 to 4 weeks follow-up
- description
- Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
- measure
- Number of patients with adverse events related to the index-procedure.
- timeFrame
- 3 months follow-up
- description
- Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age at study entry is at least 18 years. * Patient must sign and date the informed consent form prior to the index-procedure. * Patient has a tumor in the ascending colon. Exclusion Criteria: * Patient is pregnant. * Patient has inflammatory bowel disease (ulcerative colitis, Crohn's disease). * Patient has symptomatic diverticulitis. * Patient has bowel trauma. * Patient has peritoneal carcinomatosis. * Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.
References
Publications (0)
Data not yet available