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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05566249
Recruitment Status : Recruiting
First Posted : October 4, 2022
Last Update Posted : October 6, 2022
Sponsor:
Collaborators:
Asan Medical Center
Seoul St. Mary's Hospital
Chonnam National University Hospital
Severance Hospital
Seoul National University Bundang Hospital
Uijeongbu St. Mary Hospital
LivsMed
Information provided by (Responsible Party):
Jung Wook Huh, Samsung Medical Center

Tracking Information
First Submitted Date September 28, 2022
First Posted Date October 4, 2022
Last Update Posted Date October 6, 2022
Actual Study Start Date October 1, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2022)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 30, 2022)
  • Oncologic outcomes [ Time Frame: 5-year ]
    5-year Disease-free Survival
  • Oncologic outcomes [ Time Frame: 5-year ]
    5-year Overall Survival
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
Official Title A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patients with rectal or rectosigmoid junction adenocarcinoma who will be planned to undergo elective low anterior resection with double stapled technique.
Condition
  • Rectal Cancer
  • Rectosigmoid Cancer
  • Rectosigmoid Junction Cancer
Intervention Device: ArtiSential
Articulating laparoscopic instrument
Study Groups/Cohorts
  • ArtiSential group
    Patients undergoing laparoscopic surgery using ArtiSential
    Intervention: Device: ArtiSential
  • Robot group
    Patients undergoing robotic surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 30, 2022)		 1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2029
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jung Wook Huh, MD PhD +82-10-9025-7244 jungwook.huh@gmail.com
Contact: Dae HEe Pyo, MD PhD pyodaehee@gmail.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT05566249
Other Study ID Numbers SMC-2022-01-174
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Current Responsible Party Jung Wook Huh, Samsung Medical Center
Original Responsible Party Same as current
Current Study Sponsor Samsung Medical Center
Original Study Sponsor Same as current
Collaborators
  • Asan Medical Center
  • Seoul St. Mary's Hospital
  • Chonnam National University Hospital
  • Severance Hospital
  • Seoul National University Bundang Hospital
  • Uijeongbu St. Mary Hospital
  • LivsMed
Investigators Not Provided
PRS Account Samsung Medical Center
Verification Date October 2022