UMIN-ICDS Clinical Trial

Public title

A study on the usability of a new articulating laparoscopic instrument (ArtiSential) in rectal cancer surgery

Acronym

Usability study of ArtiSential in rectal cancer surgery

Scientific Title

A usability study evaluating the ArtiSential articulating instrument in transanal total mesorectal excision (TaTME)

Scientific Title:Acronym

Usability study of ArtiSential in TaTME

Region

Japan

Condition

Rectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate surgeon-reported usability of the ArtiSential monopolar electrode used in the perineal phase of transanal total mesorectal excision (TaTME).

Basic objectives2

Others

Basic objectives -Others

Assessment of usability of a surgical instrument

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Surgeon-reported usability of the ArtiSential, assessed by an anonymous questionnaire (5-point Likert scale) administered to the operating surgeon after each surgery. Usability will be considered favorable if 80% or more of all item responses across 30 cases are rated 4 or higher.

Key secondary outcomes

(1) Completion rate of surgery using ArtiSential (completion = no intraoperative use of other monopolar electrodes)
(2) Incidence of adverse events
(3) Positive circumferential resection margin (CRM) rate
(4) Complete total mesorectal excision (TME) rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Transanal total mesorectal excision (TaTME) using the ArtiSential monopolar electrode (certification number: 302AFBZI00049000) during the perineal phase; all other procedures follow routine clinical practice. After each surgery, the operating surgeon completes a usability questionnaire. Follow-up: 1 month after surgery.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria:
(1) Rectal tumor (any histology) with the lower tumor border located within 10 cm from the anal verge, scheduled to undergo TaTME
(2) Clinical T1-3, N1-2, M0
(3) Age 20 years or older at enrollment
(4) Written informed consent obtained from the patient
*High-risk T1 cases requiring additional surgical resection after prior EMR/ESD are also eligible.
(Surgeon inclusion criterion: board certification under the Endoscopic Surgical Skill Qualification System of the Japan Society for Endoscopic Surgery)

Key exclusion criteria

Patients who meet any of the following criteria are excluded:
(1) Emergency surgery
(2) Cases requiring lateral pelvic lymph node dissection
(3) Cases requiring combined resection of other organs
(4) Psychiatric disease or symptoms making participation inappropriate
(5) Inability to provide written informed consent
(6) Judged inappropriate for the study by the physician
(Surgeon exclusion criteria: surgeons who do not consent, or judged inappropriate by the investigators)

Target sample size

30

Name of lead principal investigator

1st name	Masaaki
Middle name
Last name	Ito

Organization

National Cancer Center Hospital East

Division name

Department of Colorectal Surgery

Zip code

2778577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL

04-7133-1111

Email

maito@east.ncc.go.jp

Name of contact person

1st name	Nariaki
Middle name
Last name	Okamoto

Organization

National Cancer Center Hospital East

Division name

National Cancer Center Hospital East

Zip code

2778577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL

04-7133-1111

Homepage URL

Email

naokamo2@east.ncc.go.jp

Institute

National Cancer Center

Institute

Department

Personal name

Organization

LivsMed Inc. (Republic of Korea)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Research Ethics Review Committee

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

11

Month

04

Day

Date of IRB

2025

Year

11

Month

11

Day

Anticipated trial start date

2025

Year

12

Month

01

Day

Last follow-up date

2026

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

10

Day

Last modified on

2026

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071589