Rectal CancerNCT05566249
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
An observational study of Rectal Cancer and Rectosigmoid Cancer, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Rectosigmoid Cancer, Rectosigmoid Junction Cancer
- What is being tested?
- ArtiSential
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2022to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with rectal or rectosigmoid junction adenocarcinoma who will be planned to undergo elective low anterior resection with double stapled technique.
Who may be able to join
- 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
Who cannot join
- Preoperative systemic chemotherapy
- Distant metastasis at initial diagnosis
- Palliative surgery
- Emergent surgery
- Lynch syndrome or FAP-associated cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dae HEe Pyo, MD PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Sun Wha Kim
Dae Hee Pyo, MD, PhD
About this study
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.
- Being tested
- ArtiSential
- Keywords
- laparoscopic surgery, minimally invasive surgery, robotic-assisted surgery, robotic surgery, Da Vinci system, ArtiSential, Articulating laparoscopic instrument
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtiSentialDevice
Articulating laparoscopic instrument
| Study group | Role | What they receive |
|---|---|---|
| ArtiSential group | Patients undergoing laparoscopic surgery using ArtiSential Receives: Device: ArtiSential | |
| Robot group | Patients undergoing robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical failure
conversion, postoperative complications, or less than 12 harvested lymph nodes
Measured: 1 month
Cost
Total medical cost during hospital stay for surgery
Measured: 1 month
Secondary outcomes (2)
Oncologic outcomes
5-year Disease-free Survival
Measured: 5-year
Oncologic outcomes
5-year Overall Survival
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Jung Wook Huh, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566249
- Sponsor's protocol ID
- SMC-2022-01-174
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Pyo DH, Kim S, Do M, Huh JW. Laparoscopic Ultralow Anterior Resection Using a New Articulating Device. Dis Colon Rectum. 2025 Jan 1;68(1):e5. doi: 10.1097/DCR.0000000000003287. Epub 2024 Sep 12. No abstract available.
PubMed 39264062
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
- ClinicalTrials.gov ID
- NCT05566249
- Acronym / sponsor ID
- SMC-2022-01-174
- Keywords
- laparoscopic surgery, minimally invasive surgery, robotic-assisted surgery, robotic surgery, Da Vinci system, ArtiSential, Articulating laparoscopic instrument
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- 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
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArtiSential group | – | Device: ArtiSentialPatients undergoing laparoscopic surgery using ArtiSential |
| Robot group | – | –Patients undergoing robotic surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with rectal or rectosigmoid junction adenocarcinoma who will be planned to undergo elective low anterior resection with double stapled technique.
Key inclusion criteria (7 listed)
- Age : 18 ~ 80 year old male or female
- Biopsy-proven adenocarcinoma
- Rectal cancer or Rectosigmoid junction cancer
- Primary cancer
- Non-metastatic cancer
Key exclusion criteria (5 listed)
- Preoperative systemic chemotherapy
- Distant metastasis at initial diagnosis
- Palliative surgery
- Emergent surgery
- Lynch syndrome or FAP-associated cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtiSentialArticulating laparoscopic instrument | Device | ArtiSential group |
Primary outcome
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
2 secondary outcomes
Oncologic outcomes
Time frame: 5-year
Oncologic outcomes
Time frame: 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Derived from this study: PubMed 39264062Pyo DH, Kim S, Do M, Huh JW. Laparoscopic Ultralow Anterior Resection Using a New Articulating Device. Dis Colon Rectum. 2025 Jan 1;68(1):e5. doi: 10.1097/DCR.0000000000003287. Epub 2024 Sep 12. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dae HEe Pyo, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Rectosigmoid Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung Wook Huh, MD PhD (+82-10-9025-7244, jungwook.huh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical failure (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.