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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

Study Description
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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.

Condition or disease Intervention/treatment
Rectal Cancer Rectosigmoid Cancer Rectosigmoid Junction Cancer Device: ArtiSential

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2029
Groups and Cohorts
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Group/Cohort Intervention/treatment
ArtiSential group
Patients undergoing laparoscopic surgery using ArtiSential
 Device: ArtiSential
Articulating laparoscopic instrument
Robot group
Patients undergoing robotic surgery


Outcome Measures
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Primary Outcome Measures :
  1. Surgical failure [ Time Frame: 1 month ]
    conversion, postoperative complications, or less than 12 harvested lymph nodes

  2. Cost [ Time Frame: 1 month ]
    Total medical cost during hospital stay for surgery


Secondary Outcome Measures :
  1. Oncologic outcomes [ Time Frame: 5-year ]
    5-year Disease-free Survival

  2. Oncologic outcomes [ Time Frame: 5-year ]
    5-year Overall Survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05566249


Contacts
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Contact: Jung Wook Huh, MD PhD +82-10-9025-7244 jungwook.huh@gmail.com
Contact: Dae HEe Pyo, MD PhD pyodaehee@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sun Wha Kim         
Sub-Investigator: Dae Hee Pyo, MD, PhD         
Principal Investigator: Jung Wook Huh, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Asan Medical Center
Seoul St. Mary's Hospital
Chonnam National University Hospital
Severance Hospital
Seoul National University Bundang Hospital
Uijeongbu St. Mary Hospital
LivsMed
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jung Wook Huh, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT05566249    
Other Study ID Numbers: SMC-2022-01-174
First Posted: October 4, 2022    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022

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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
Keywords provided by Jung Wook Huh, Samsung Medical Center:
laparoscopic surgery
minimally invasive surgery
robotic-assisted surgery
robotic surgery
 Da Vinci system
ArtiSential
Articulating laparoscopic instrument
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases