Recruiting NCT05566249
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ArtiSential.
- Who it may be relevant to
- Registry conditions: Rectal Cancer, Rectosigmoid Cancer, Rectosigmoid Junction Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device ArtiSential
Articulating laparoscopic instrument
Primary outcome measures
- Surgical failure [Time frame: 1 month]
- Cost [Time frame: 1 month]
Secondary outcome measures (2)
- Oncologic outcomes [Time frame: 5-year]
- Oncologic outcomes [Time frame: 5-year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Publications
- Pyo 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
Identifiers
NCT: NCT05566249 · SMC-2022-01-174