ATOMen study

JRCT ID: jRCT1042230164

Registered date:06/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: endometrial cancer
• Date of first enrollment: 03/06/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Operate using the hinotori surgical robotics and collect surgical images and operation logs.

Outcome(s)

• Primary Outcome: Relation between goals and robot operation logs corresponding to specific motions/sections
• Secondary Outcome: Performance evaluation of hinotori regarding achievement targets corresponding to specific movements and sections

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

(1) The age at the time of obtaining consent is 18 years or older for women.
(2) ECOG performance status (PS) is 0 or 1.
(3) A biopsy of the endometrial primary lesion strongly suspects or diagnoses endometrioid carcinoma histologically. The main occupying site of the tumor is the endometrium.
(4) Radical resection is planned for clinical stage I.
(5) Major organ functions are preserved.
(6) After sufficient explanation of the trial details prior to registration, written consent has been obtained from the patient themselves.

Exclude criteria

(1) Previous chemotherapy or radiation therapy for the target disease, or previous radiation therapy involving the abdomen.
(2) Previous abdominal surgery (Excluded appendectomy and cesarean section).
(3) Patients who are judged to be unsuitable by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Takanashi Nobutaka
• Secondary Sponsor: Sysmex Corporation