Status:
UNKNOWN
Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy
Lead Sponsor:
Jing Liang
Conditions:
Gynecologic Surgery
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women undergoing laparo...
Eligibility Criteria
Inclusion
- Pre- and Peri-menopausal woman patient age 18-65 years
- Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy.
- Normal Pap smear result within one year
- The uterus is larger than 12 weeks of gestation
- The body mass index of the patients is 18.5-27.9kg/m2
- Signed informed consent form
Exclusion
- Women with Known or suspected malignancy
- patients during pregnancy and lactation
- Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
- Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
- Patients who are known to have participated in any other clinical trial within 3 months
- Patients who cannot sign informed consent
- Patients with acute stage infection of the reproductive system or other sites
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 26 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04423172
Start Date
June 16 2020
End Date
December 26 2022
Last Update
June 9 2020
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