Validation of a new laparoscopic instrument for colorectal cancer surgery
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
Samsung Medical Center · NCT05566249
This study is testing a new surgical tool for colorectal cancer surgery to see if it is safe and works well compared to robotic surgery techniques for patients with rectal and rectosigmoid junction cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05566249 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the safety and feasibility of the ArtiSential articulating laparoscopic instrument in colorectal surgeries, specifically for patients with rectal and rectosigmoid junction cancers. It will compare the outcomes of surgeries performed with ArtiSential against those conducted using robotic surgery techniques. The study is observational and will utilize a multi-center registry to gather data on surgical outcomes and patient safety. Participants will be closely monitored to assess the effectiveness of this innovative surgical tool.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with biopsy-proven non-metastatic rectal or rectosigmoid junction adenocarcinoma scheduled for elective curative surgery.
Not a fit: Patients who have distant metastasis, require palliative surgery, or have undergone preoperative systemic chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and recovery for patients undergoing colorectal cancer surgery.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, suggesting that this approach may also yield positive outcomes, although the specific use of ArtiSential is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Jung Wook Huh, MD PhD
- Email: jungwook.huh@gmail.com
- Phone: +82-10-9025-7244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer, Rectosigmoid Cancer, Rectosigmoid Junction Cancer, laparoscopic surgery, minimally invasive surgery, robotic-assisted surgery, robotic surgery, Da Vinci system