Clinical Study on a Novel Anti-adhesion Barrier Film

Launched by THE FOURTH AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Jun 2, 2023

Keywords

ClinConnect Summary

**Summary of the Clinical Trial on a New Anti-adhesion Barrier Film**

This clinical trial is studying a new device called an anti-adhesion diaphragm, which aims to prevent a condition known as intrauterine adhesion. Intrauterine adhesions can happen after procedures like a miscarriage or a curettage (a cleaning of the uterus), and they may affect a woman's reproductive health. The trial is currently looking for women aged 18 to 40 who have experienced an early pregnancy abortion or a cleanse and who are willing to participate by providing their informed consent.

If you or a loved one is considering participating, it's important to know the eligibility requirements. The study cannot accept women with certain conditions, such as scars in the reproductive area, allergies, severe infections, or specific reproductive organ issues. Participants will be monitored for safety and effectiveness while using the diaphragm. Overall, this trial is a chance to help improve treatment options for women facing intrauterine adhesions while contributing to important medical research.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily participate in this trial and sign a written informed consent;
• • Women aged 18 ≤ age ≤ 40 years;
• • Those who had an abortion in early pregnancy, and those who had a cleanse.
• Exclusion Criteria:
• • Patients with scars;
• • Patients with allergies;
• • Patients with acute genitourinary tract infections;
• • Patients with abnormalities of reproductive organs and abnormal uterine flexion after cesarean section;
• • Patients with decreased menstrual flow after previous curettage;
• • Patients with previous suspected or diagnosed uterine adhesions;
• • Patients on immunosuppressive drugs;
• • Patients with long-term use of antibiotics;
• • Patients with malignant tumors of the reproductive organs;
• • Patients with uterine adenomyosis, endometriosis, and uterine fibroids;
• • Patients with severe systemic diseases;
• • Patients with other conditions that are not suitable.