study to demonstrate the safety of Medical Device

Not Applicable

• Conditions: Health Condition 1: N921- Excessive and frequent menstruation with irregular cycle

• Registration Number: CTRI/2019/09/021038
• Lead Sponsor: PregnanTech Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Female subjects before menopause, aged 20 to 45 years, both inclusive.

2. Subjects undergoing planned total hysterectomy (including full length of the cervix) either total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) for various benign indications.

3. Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan.

4. Subject whose screening laboratory values are within normal range or are considered clinically not significant by the Principal Investigator

5. Subjects with history of previous delivery(ies)

6. Subjects with negative serum pregnancy test at screening.

Exclusion Criteria

1. Subjects undergoing subtotal hysterectomy, not including the cervix

2. Subjects with low fibroids close to the cervix

3. Subjects undergoing hysterectomy for malignancy

4. History of cervical intraepithelial neoplasia (CIN) or cervical cancer

5. History of cervical conization

6. Subjects with an IUD

7. Subjects with positive test for HIV, HBV or HCV

8. Subjects with history of tuberculosis affecting the reproductive organs

9. History of cervicitis, vaginitis or vaginal ulcerative disease

10. Vaginismus

11. Subjects with bleeding disorders (excluding menorrhagia or metrorrhagia)

12. Known sensitivity, contraindication or intolerance to silicone

13. Has a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the CIP

14. Subject is currently participating or has participated in another clinical trial within the past 30 days prior to screening

15. Any coexisting serious or uncontrolled comorbid condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility to deploy the Lioness© pessary of PregnanTech Ltd. as per instructions of use <br/ ><br>To evaluate the safety of the Lioness© pessary of PregnanTech Ltd. in patients undergoing total hysterectomy for various benign conditions <br/ ><br>Timepoint: Cohort 01: Device will be inserted in the operating room just before hysterectomy <br/ ><br>Cohort 02: Device will be inserted 48 hours (± 6 hours) before hysterectomy <br/ ><br>Cohort 03: Device will be inserted 7 (± 2 days) days before hysterectomy <br/ ><br>Cohort 04: Device will be inserted 21 days (± 5 days) before hysterectomy <br/ ><br>Cohort 05: Device will be inserted 45 days (± 7 days) before hysterectomy <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Incidence of complications and adverse events during the device placement <br/ ><br>Incidence of complications and adverse events until the removal of the Lioness© pessary <br/ ><br>Incidence of pain, vaginal discharge and discomfort from the time of device placement until device removal <br/ ><br>Timepoint: Cohort 01: Device will be inserted in the operating room just before hysterectomy <br/ ><br>Cohort 02: Device will be inserted 48 hours (± 6 hours) before hysterectomy <br/ ><br>Cohort 03: Device will be inserted 7 (± 2 days) days before hysterectomy <br/ ><br>Cohort 04: Device will be inserted 21 days (± 5 days) before hysterectomy <br/ ><br>Cohort 05: Device will be inserted 45 days (± 7 days) before hysterectomy <br/ ><br>