NicheNCT06656286
Hysteroscopic Intrauterine Suturing
A study testing Intra-Uterine suturing by X-TACK device and hysteroscope in people with Niche and Uterine Disease, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Niche, Uterine Disease
- What is being tested?
- Intra-Uterine suturing by X-TACK device and hysteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- 12 May 2025to 2 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign indication for hysterectomy
Who cannot join
- Evidence or suspicious for malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study
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.
Read the detailed description
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.
- Conditions
- Niche, Uterine Disease
- Being tested
- Intra-Uterine suturing by X-TACK device and hysteroscope
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Uterine suturing by X-TACK device and hysteroscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing laparoscopic hysterectomy | Experimental | Women undergoing laparoscopic hysterectomy for benign indication with no evidence or suspicious for malignancy. Receives: Device: Intra-Uterine suturing by X-TACK device and hysteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus.
When the uterus will be opened the suture will be observed.
Measured: Immediately after the procedure.
Secondary outcomes (1)
Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury.
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start12 May 2025
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NicheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656286
- Sponsor's protocol ID
- EMC-0086-24
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34913810Umranikar 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.
PubMed 28003797Bahar 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.
PubMed 23453765
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study
- ClinicalTrials.gov ID
- NCT06656286
- Acronym / sponsor ID
- EMC-0086-24
- Conditions
- Niche, Uterine Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing laparoscopic hysterectomy | Experimental | Device: Intra-Uterine suturing by X-TACK device and hysteroscopeWomen undergoing laparoscopic hysterectomy for benign indication with no evidence or suspicious for malignancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Benign indication for hysterectomy
Key exclusion criteria (1 listed)
- Evidence or suspicious for malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-Uterine suturing by X-TACK device and hysteroscopeAfter 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. | Device | Women undergoing laparoscopic hysterectomy |
Primary outcome
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.
1 secondary outcome
Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury.
Time frame: Immediately after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 34913810Vila 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.
- Background: PubMed 28003797Umranikar 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.
- Background: PubMed 23453765Bahar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Uterine suturing by X-TACK device and hysteroscope in people with Niche and Uterine Disease, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus. (time frame: Immediately after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656286, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.