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A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry

A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05566249
Enrollment
1000
Registered
2022-10-04
Start date
2022-10-01
Completion date
2029-12-31
Last updated
2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer, Rectosigmoid Cancer, Rectosigmoid Junction Cancer

Keywords

laparoscopic surgery, minimally invasive surgery, robotic-assisted surgery, robotic surgery, Da Vinci system, ArtiSential, Articulating laparoscopic instrument

Brief summary

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

DEVICEArtiSential

Articulating laparoscopic instrument

Sponsors

Asan Medical Center
CollaboratorOTHER
Seoul St. Mary's Hospital
CollaboratorOTHER
Chonnam National University Hospital
CollaboratorOTHER
Severance Hospital
CollaboratorOTHER
Seoul National University Bundang Hospital
CollaboratorOTHER
Uijeongbu St. Mary Hospital
CollaboratorOTHER
LivsMed
CollaboratorUNKNOWN
Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical failure1 monthconversion, postoperative complications, or less than 12 harvested lymph nodes
Cost1 monthTotal medical cost during hospital stay for surgery

Secondary

MeasureTime frameDescription
Oncologic outcomes5-year5-year Disease-free Survival

Countries

South Korea

Contacts

Primary ContactJung Wook Huh, MD PhD
jungwook.huh@gmail.com+82-10-9025-7244
Backup ContactDae HEe Pyo, MD PhD
pyodaehee@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026