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NOT YET RECRUITING
NCT06656286
NA

Hysteroscopic Intrauterine Suturing

Sponsor: HaEmek Medical Center, Israel

View on ClinicalTrials.gov

Summary

Clinical trial The aim of the study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack, inserted into the uterus by hysteroscope. Primary outcome: Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed. Secondary outcome: Procedure complications. Study Design Interventional pilot Study Study group: Women undergoing laparoscopic hysterectomy.

Official title: Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2

Start Date

2025-04-25

Completion Date

2026-07-02

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

DEVICE

Intra-Uterine suturing by X-TACK device and hysteroscope

After general anesthesia and entering the abdomen with the laparoscope, Truclear hysteroscope with X-tack attached will be inserted to the uterine cavity. Insertion of normal saline to the cavity and applying 4 points suturing to the uterus. The procedure will be monitored by external laparoscopic camera located in the abdominal cavity. After the hysterectomy the uterus will be opened and the suture will be examine. A preoperative intrauterine incision using a hysteroscope, followed by suturing, will be considered based on the success of the first procedure.

Locations (1)

Emek Medical Center

Afula, Israel