Hysteroscopic Intrauterine Suturing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHaEmek Medical Center, Israel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Benign indication for hysterectomy
Disqualifiers
Evidence or suspicious for malignancy
Trial design
Design model
Single group
Treatments tested in this trial
Intra-Uterine suturing by X-TACK device and hysteroscope
DeviceAfter 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.
Treatment groups
2 Participants
are divided into 1 treatment groupGroup A: Women undergoing laparoscopic hysterectomyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Immediately after the procedure.Secondary outcomes
1
Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury.
Time frame
Immediately after the procedure.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: