Clinical trial of TRM-270 for patients undergoing pelvic cavity surgery in the field of obstetrics and gynecology

JRCT ID: jRCT2032230476

Registered date:25/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who are scheduled to undergo pelvic cavity surgery in the field of obstetrics and gynecolo
• Date of first enrollment: 25/11/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Application of an anti-adhesion absorbent barrier

Outcome(s)

• Primary Outcome: Safety

Key inclusion & exclusion criteria

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

Include criteria

1. Female patients aged between 18 years or older at the time of informed consent
2. Patients who are fully informed about this study prior to the participation, understand the content, and give a written informed consent of their own free will
3. Patients who are scheduled to undergo pelvic cavity surgery in the field of obstetrics and gynecology (Uterine fibroid, Caesarean section, Ovarian cyst, etc.)

Exclude criteria

1. Patients with any of the following complications:
a. Peritonitis
b. Intra-abdominal or pelvic infections
c. Hypersensitivity to components of TRM-270 including metabolites such as polyethylene glycol
d. Malignant tumor
e. Severe diabetes or glucose metabolism disorder
2. Patients with any of the following history:
a. Intra-abdominal or pelvic surgery except appendicitis surgery and cesarean section
b. Peritonitis
c. Malignant tumor
3. Patients who are suspected of endometriosis of r-ASRM stage III (Moderate) or greater
4. Patients with severe acute or chronic clinical symptoms, mental status, or abnormal laboratory test value that the investigator has determined to be ineligible for conducting this trial because there is a possibility that the risks may increase or the interpretation of clinical trial results may be affect
5. Patients who are positive for pregnancy test prior to enrollment (except for patient who meet inclusion criteria 3 for caesarean section) or want to become pregnant during the clinical trial
6. Patients who are participating in other clinical trials or clinical studies (including clinical trials) that may affect the evaluation of this clinical trial, or who have participated within 30 days before consent was obtained
7. Patients who judged by the investigators to be unsuitable for conducting this clinical trial

Related Information

• Primary Sponsor: Sawae Juichi