NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2072230083

Registered date:07/11/2023

Safety confirmation study with dMD-003

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUterine leiomyoma
Date of first enrollment12/04/2024
Target sample size30
Countries of recruitment
Study typeInterventional
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 OutcomeIncidence of adverse events up to 12 weeks after surgery.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
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

Contact

Public contact
Name Public relations
Address 7, Yotsuya 1-chome, Shinjuku-ku, Tokyo Tokyo Japan 160-8515
Telephone +81-3-3225-6303
E-mail webmaster@mochida.co.jp
Affiliation Mochida Pharmaceutical Co., Ltd.
Scientific contact
Name Fumiaki Aihara
Address 7, Yotsuya 1-chome, Shinjuku-ku, Tokyo Tokyo Japan 160-8515
Telephone +81-3-3225-6306
E-mail dmd003.mdbd@mochida.co.jp
Affiliation Mochida Pharmaceutical Co., Ltd.