Emek Medical Center
Afula, Israel
NCT Number: NCT06656286
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Afula, Israel
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Immediately after the procedure.
When the uterus will be opened the suture will be observed.
Time frame: Immediately after the procedure.
Contact information is provided by the study sponsor or research team.
HaEmek Medical Center, Israel
Other
Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study
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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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