An Open-label Study of SI-449 in Patients Undergoing Laparoscopic Uterine Myomectomy.

JRCT ID: jRCT2072210100

Registered date:23/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Uterine myoma
• Date of first enrollment: 27/01/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): SI-449 Resorbable Adhesion Barrier System will be applied to subjects undergoing laparoscopic uterine myomectomy.

Outcome(s)

• Primary Outcome: Operability, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female
• Include criteria: Subjects undergoing laparoscopic uterine myomectomy.

Exclude criteria

1. Subjects with history of surgery in the abdominal or pelvic cavity.
2. Subjects with having active infection in the abdominal or pelvic cavity.
3. Subjects with history of hypersensitivity to the investigational device.
4. Subjects with a serious hepatic or a serious renal disorder.
5. Subjects who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent.

Related Information

• Primary Sponsor: Sagawa Kenji