Hysteroscopic Intrauterine Suturing

March 12, 2025 updated by: HaEmek Medical Center, Israel

Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

A hysteroscopy is a procedure used to examine and treat the inside of the uterus.

Apollo X-tack is an endoscopic apparatus for stomach defect closure by gastroscopy.

The aim of this study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack inserted into the uterus by hysteroscope.

Study Design Interventional pilot study

Study group:

Women undergoing laparoscopic hysterectomy.

Inclusion criteria:

Benign indication for hysterectomy

Exclusion from the study:

Evidence or suspicious for malignancy

Sample size calculation:

Pilot study of 2 patients.

Primary outcome:

Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed.

Secondary outcome:

Procedure complications.

Recruitment:

The recruitment of the patients will be done at the gynecology department before the surgery.

Procedure:

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.

CRF:

Demographics information, obstetrics and gynecology information, surgery type, surgery indication.

Procedure duration, success, amount of fluid used, cervical dilatation, complications.

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Afula, Israel
        • Emek Medical Center
        • Contact:
        • Contact:
          • Adi Dayan-Schwartz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Benign indication for hysterectomy

Exclusion Criteria:

  • Evidence or suspicious for malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women undergoing laparoscopic hysterectomy
Women undergoing laparoscopic hysterectomy for benign indication with no evidence or suspicious for malignancy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus.
Time Frame: Immediately after the procedure.
When the uterus will be opened the suture will be observed.
Immediately after the procedure.

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury.
Time Frame: Immediately after the procedure.
Immediately after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

July 2, 2026

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMC-0086-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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