Hysteroscopic Intrauterine Suturing

NCT06656286 | Not Yet Recruiting FDA Device

• 1 other identifier: EMC-0086-24
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus.

  When the uterus will be opened the suture will be observed.

  Immediately after the procedure.

Secondary Outcomes (1)

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

  Immediately after the procedure.

Study Arms (1)

Women undergoing laparoscopic hysterectomy

EXPERIMENTAL

Women undergoing laparoscopic hysterectomy for benign indication with no evidence or suspicious for malignancy.

Device: Intra-Uterine suturing by X-TACK device and hysteroscope

Interventions

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.

Women undergoing laparoscopic hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Benign indication for hysterectomy

You may not qualify if:

• Evidence or suspicious for malignancy

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Emek Medical Center

Afula, Israel

Location

Related Publications (3)

• Vila Famada A, Cos Plans R, Costa Canals L, Rojas Torrijos M, Rodriguez Vicente A, Bainac Albadalejo A. Outcomes of surgical hysteroscopy: 25 years of observational study. J Obstet Gynaecol. 2022 Jul;42(5):1365-1369. doi: 10.1080/01443615.2021.1971176. Epub 2021 Dec 16.

  PMID: 34913810 BACKGROUND

• Umranikar S, Clark TJ, Saridogan E, Miligkos D, Arambage K, Torbe E, Campo R, Di Spiezio Sardo A, Tanos V, Grimbizis G; British Society for Gynaecological Endoscopy /European Society for Gynaecological Endoscopy Guideline Development Group for Management of Fluid Distension Media in Operative Hysteroscopy. BSGE/ESGE guideline on management of fluid distension media in operative hysteroscopy. Gynecol Surg. 2016;13(4):289-303. doi: 10.1007/s10397-016-0983-z. Epub 2016 Oct 6. No abstract available.

  PMID: 28003797 BACKGROUND

• Bahar R, Shimonovitz M, Benshushan A, Shushan A. Case-control study of complications associated with bipolar and monopolar hysteroscopic operations. J Minim Invasive Gynecol. 2013 May-Jun;20(3):376-80. doi: 10.1016/j.jmig.2012.12.012. Epub 2013 Feb 27.

  PMID: 23453765 BACKGROUND

MeSH Terms

Conditions

Uterine Diseases

Interventions

Hysteroscopes

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Adi Dayan Schwartz, MD

CONTACT

+972-4-6494331; adi.schwartz1@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 24, 2024
• Study Start: April 25, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: March 13, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)