Samsung Medical Center
Seoul, South Korea
Location status: Recruiting
Location contact
Dae Hee Pyo, MD, PhD
SUB_INVESTIGATOR
Jung Wook Huh, MD, PhD
PRINCIPAL_INVESTIGATOR
Sun Wha Kim
CONTACT
Recruiting
NCT Number: NCT05566249
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ArtiSential
DeviceArticulating laparoscopic instrument
Primary outcomes
-
Surgical failure
Time frame: 1 month
conversion, postoperative complications, or less than 12 harvested lymph nodes
-
Cost
Time frame: 1 month
Total medical cost during hospital stay for surgery
Secondary outcomes
-
Oncologic outcomes
Time frame: 5-year
5-year Disease-free Survival
-
Oncologic outcomes
Time frame: 5-year
5-year Overall Survival
Study contacts
Contact information is provided by the study sponsor or research team.
Dae HEe Pyo, MD PhD
CONTACT
Jung Wook Huh, MD PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Samsung Medical Center
Other
Collaborators
- Asan Medical Center
- Chonnam National University Hospital
- LivsMed
- Seoul National University Bundang Hospital
- Seoul St. Mary's Hospital
- Severance Hospital
- Uijeongbu St. Mary Hospital
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2029
- First posted
- Oct 4, 2022
- Registry last updated
- Oct 6, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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