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NCT05566249 Clinical Trial

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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05566249
Other study ID # SMC-2022-01-174
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2029

Study information
Verified date October 2022
Source Samsung Medical Center
Contact Jung Wook Huh, MD PhD
Phone +82-10-9025-7244
Email jungwook.huh@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2029
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ArtiSential
Articulating laparoscopic instrument

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (8)
Lead Sponsor Collaborator
Samsung Medical Center Asan Medical Center, Chonnam National University Hospital, LivsMed, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Severance Hospital, Uijeongbu St. Mary Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical failure conversion, postoperative complications, or less than 12 harvested lymph nodes 1 month
Primary Cost Total medical cost during hospital stay for surgery 1 month
Secondary Oncologic outcomes 5-year Disease-free Survival 5-year
Secondary Oncologic outcomes 5-year Overall Survival 5-year
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