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Clinical Trials/JPRN-jRCT2032230476
JPRN-jRCT2032230476
Recruiting
未知

A clinical trial to evaluate the safety and operability of TRM-270 for patients undergoing pelvic cavity surgery in the field of obstetrics and gynecology

Sawae Juichi0 sites30 target enrollmentNovember 25, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Patients who are scheduled to undergo pelvic cavity surgery in the field of obstetrics and gynecolo
Sponsor
Sawae Juichi
Enrollment
30
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 25, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Sawae Juichi

Eligibility Criteria

Inclusion 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.)

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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