Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 5:30 AM
Study NCT ID:
NCT06442605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
Sponsor:
First People's Hospital of Hangzhou
Organization:
Study Overview
Official Title:
Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal.
Research Design This study is a single-center, randomized, single-blind, 1:1 controlled trial.
Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups.
Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.
Control group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.
Observation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity).
Secondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.
Research Design This study is a single-center, randomized, single-blind, 1:1 controlled trial.
Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups.
Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.
Control group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.
Observation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity).
Secondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: