Clinical trial · Interventional
Evaluating the Safety and Effectiveness of the Flex Robotic System for the Surgical Removal of Colorectal Lesions
Feasibility of Transanal Robot-Assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study
- 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)
This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.
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 Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
| Endoscopic Ultrasound | Procedure | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Device Feasibility (Flex Robotic System)
- description
- Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
- interventionNames
- Procedure: Colonoscopy
- Procedure: Endoscopic Ultrasound
- Other: Medical Chart Review
- Other: Medical Device Usage and Evaluation
- Procedure: Resection
Primary outcomes (2)
- measure
- Rates of complete en bloc resection
- timeFrame
- Up to 2 years
- description
- Rates of complete en bloc resection
- measure
- Incidence of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 22 years (minimum age approved for use) * Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification * Colorectal lesions situated between 5 and 15 cm from the dentate line * Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter * Colorectal subepithelial lesions \< 2 cm in size * Absence of uncorrectable bleeding disorder or coagulopathy * Platelet count \> 50,000 * International normalized ratio (INR) \< 1.5 * Ability to give informed consent Exclusion Criteria: * Inability to receive general anesthesia * Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy) * Excavated (0-III) colorectal lesions according to Paris classification * Suboptimal colon preparation * Clinical discretion of the provider
References
Publications (0)
Data not yet available