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

An Open-label Study of SI-449 Resorbable Adhesion Barrier System in Patients Undergoing Laparoscopic Uterine Myomectomy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2072210100

Enrollment

Registered

2021-12-23

Start date

2022-01-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine myoma

Interventions

SI-449 Resorbable Adhesion Barrier System will be applied to subjects undergoing laparoscopic uterine myomectomy.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Subjects undergoing laparoscopic uterine myomectomy.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Operability, safety	—

Contacts

Public ContactKumi Ando

SEIKAGAKU CORPORATION

reply@seikagaku.co.jp+81-3-5220-8593

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026