Safety confirmation study with dMD-003

JRCT ID: jRCT2072230083

Registered date:07/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Uterine leiomyoma
• Date of first enrollment: 01/10/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The study device (dMD-003) is applied to the injury site of the uterus immediately before wound closure in uterine myomectomy.

Outcome(s)

• Primary Outcome: Incidence of adverse events up to 12 weeks after surgery.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

(1) Patients scheduled to undergo laparoscopic, laparoscopy-assisted, or open uterine myomectomy.
Other criteria.

Exclude criteria

(1) Patients who have undergone surgery in the abdominal or pelvic cavity (excluding surgery for appendicitis).
(2) Patients with concurrent active pelvic inflammatory disease or peritonitis.
(3) Patients suspected of having moderate (stage III) or severe endometriosis according to the r-ASRM classification.
Other criteria.

Related Information

• Primary Sponsor: Aihara Fumiaki