Clinical trial · Observational
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
NCT05566249CI-TRIAL-00061284recruitingClinicalTrials.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)
This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectosigmoid Cancer | Malignant Rectosigmoid Neoplasm | ALIAS | 0.90 |
| Rectosigmoid Junction Cancer | Rectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ArtiSential | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ArtiSential group
- description
- Patients undergoing laparoscopic surgery using ArtiSential
- interventionNames
- Device: ArtiSential
- label
- Robot group
- description
- Patients undergoing robotic surgery
Primary outcomes (2)
- measure
- Surgical failure
- timeFrame
- 1 month
- description
- conversion, postoperative complications, or less than 12 harvested lymph nodes
- measure
- Cost
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age : 18 \~ 80 year old male or female * Biopsy-proven adenocarcinoma * Rectal cancer or Rectosigmoid junction cancer * Primary cancer * Non-metastatic cancer * Planned (or elective) curative resection * Low anterior resection with double-stapled technique Exclusion Criteria: * Preoperative systemic chemotherapy * Distant metastasis at initial diagnosis * Palliative surgery * Emergent surgery * Lynch syndrome or FAP-associated cancer
References
Publications (1)
- DERIVEDPyo DH, Kim S, Do M, Huh JW. Laparoscopic Ultralow Anterior Resection Using a New Articulating Device. Dis Colon Rectum. 2025 Jan 1;68(1):e5. doi: 10.1097/DCR.0000000000003287. Epub 2024 Sep 12. No abstract available. PMID 39264062