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Hysteroscopic Intrauterine Suturing

NCT06656286 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Niche
  • Uterine Disease

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.

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2026-01-01
Completion
2026-07-02
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656286 on ClinicalTrials.gov