Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2 participants
INTERVENTIONAL
2025-04-25
2026-07-02
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Women undergoing laparoscopic hysterectomy
Women undergoing laparoscopic hysterectomy for benign indication with no evidence or suspicious for malignancy.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Locations
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Emek Medical Center
Afula, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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EMC-0086-24
Identifier Type: -
Identifier Source: org_study_id
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