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Trial Title:
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
NCT ID:
NCT05566249
Condition:
Rectal Cancer
Rectosigmoid Cancer
Rectosigmoid Junction Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
laparoscopic surgery
minimally invasive surgery
robotic-assisted surgery
robotic surgery
Da Vinci system
ArtiSential
Articulating laparoscopic instrument
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
ArtiSential
Description:
Articulating laparoscopic instrument
Arm group label:
ArtiSential group
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.
Criteria for eligibility:
Study pop:
The patients with rectal or rectosigmoid junction adenocarcinoma who will be planned to
undergo elective low anterior resection with double stapled technique.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun Wha Kim
Investigator:
Last name:
Dae Hee Pyo, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jung Wook Huh, MD, PhD
Email:
Principal Investigator
Start date:
October 1, 2022
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Collaborator:
Agency:
Asan Medical Center
Agency class:
Other
Collaborator:
Agency:
Seoul St. Mary's Hospital
Agency class:
Other
Collaborator:
Agency:
Chonnam National University Hospital
Agency class:
Other
Collaborator:
Agency:
Severance Hospital
Agency class:
Other
Collaborator:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Collaborator:
Agency:
Uijeongbu St. Mary Hospital
Agency class:
Other
Collaborator:
Agency:
LivsMed
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566249
