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NCT Number: NCT06656286

Hysteroscopic Intrauterine Suturing

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Benign indication for hysterectomy

Exclusion criteria

  • Evidence or suspicious for malignancy

Treatment and study plan

Intra-Uterine suturing by X-TACK device and hysteroscope

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury.

    Time frame: Immediately after the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Adi Dayan Schwartz, MD

CONTACT

[email protected]

+972-4-6494331

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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