HysterectomyNCT04109989
Clinical Assessment - HominisTM Surgical System
A study testing HominisTM Surgical System in people with Hysterectomy, run by Memic Innovative Surgery at 2 sites in 2 countries.
Trial summary
A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- HominisTM Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Nov 2018to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Female above 18 years of age inclusive.
- Able to provide written informed consent.
- Eligible for Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriate indication to go through this surgery.
- Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System.
- Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
- Can undergo general anesthesia per anesthesiologist assessment.
Who cannot join
- Women with anatomical hazard for laparoscopy and/or vaginal and/or pouch of Douglas access (such as diagnosis of Crohn's disease, active Pelvic inflammatory disease (PID), active diverticulitis, sever peritoneal adhesions, frozen pelvis, obliterated vagina or sever recto-vaginal endometriosis).
- Women after pelvic radiation.
- Women diagnosed with active intra-abdominal malignancy.
- Women with general condition or illness incompatible for surgery.
- Women who are pregnant.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.
- Conditions
- Hysterectomy
- Being tested
- HominisTM Surgical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HominisTM Surgical SystemDevice
Trans-vaginal gynecological procedures
| Study group | Role | What they receive |
|---|---|---|
| HominisTM Surgical System | Experimental | Gynecological surgical procedure will be performed with the HominisTM Surgical System Receives: Device: HominisTM Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversion
Rate of conversion to open or laparoscopic approach
Measured: Intra Operative
Secondary outcomes (12)
Intra-operative & post-operative procedural outcomes
Intra-operative \& post-operative complications
Measured: Intra-operative and six weeks post procedure
Intra-operative & post-operative procedural outcomes
adverse events (AE and SAE)
Measured: Intra-operative & six weeks post procedure
Intra-operative & post-operative procedural outcomes
Bladder injury rate
Measured: Intra-operative & six weeks post procedure
Intra-operative & post-operative procedural outcomes
Rectal injury rate
Measured: Intra-operative & six weeks post procedure
Intra-operative procedural outcomes
Operative time
Measured: Intra-operative
Intra-operative & post-operative procedural outcomes
Transfusion rate
Measured: Intra-operative & six weeks post procedure
Intra-operative procedural outcomes
Conversion rate (to laparotomy, laparoscopy, other ports used in addition to vaginal and umbilical port).
Measured: Intra-operative
Intra-operative & post-operative procedural outcomes
Mortality
Measured: Intra-operative & six weeks post procedure
Post-operative procedural outcomes
Length of hospital stay
Measured: Six weeks post procedure
Post-operative procedural outcomes
Re-admission rate
Measured: Six weeks post procedure
Post-operative procedural outcomes
Re-operation rate
Measured: Six weeks post procedure
Vaginal tissue healing
Vaginal tissue healing will be assessed
Measured: Six weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start8 Nov 2018
- Primary completion1 Dec 2021
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memic Innovative Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109989
- Sponsor's protocol ID
- MEMIC-5083
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment - HominisTM Surgical System
- ClinicalTrials.gov ID
- NCT04109989
- Acronym / sponsor ID
- MEMIC-5083
- Conditions
- Hysterectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Memic Innovative SurgeryIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Oct 2019 (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.
A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HominisTM Surgical System | Experimental | Device: HominisTM Surgical SystemGynecological surgical procedure will be performed with the HominisTM Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female above 18 years of age inclusive.
- Able to provide written informed consent.
- Eligible for Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriate indication to go through this surgery.
- Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System.
- Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
Key exclusion criteria (6 listed)
- Women with anatomical hazard for laparoscopy and/or vaginal and/or pouch of Douglas access (such as diagnosis of Crohn's disease, active Pelvic inflammatory disease (PID), active diverticulitis, sever peritoneal adhesions, frozen pelvis, obliterated vagina or sever recto-vaginal endometriosis).
- Women after pelvic radiation.
- Women diagnosed with active intra-abdominal malignancy.
- Women with general condition or illness incompatible for surgery.
- Women who are pregnant.
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 |
|---|---|---|
| HominisTM Surgical SystemTrans-vaginal gynecological procedures | Device | HominisTM Surgical System |
Primary outcome
Rate of conversion
Time frame: Intra Operative
Rate of conversion to open or laparoscopic approach
12 secondary outcomes
Intra-operative & post-operative procedural outcomes
Time frame: Intra-operative and six weeks post procedure
Intra-operative & post-operative procedural outcomes
Time frame: Intra-operative & six weeks post procedure
Intra-operative & post-operative procedural outcomes
Time frame: Intra-operative & six weeks post procedure
Intra-operative & post-operative procedural outcomes
Time frame: Intra-operative & six weeks post procedure
Intra-operative procedural outcomes
Time frame: Intra-operative
Intra-operative & post-operative procedural outcomes
Time frame: Intra-operative & six weeks post procedure
Intra-operative procedural outcomes
Time frame: Intra-operative
Intra-operative & post-operative procedural outcomes
Time frame: Intra-operative & six weeks post procedure
Post-operative procedural outcomes
Time frame: Six weeks post procedure
Post-operative procedural outcomes
Time frame: Six weeks post procedure
Post-operative procedural outcomes
Time frame: Six weeks post procedure
Vaginal tissue healing
Time frame: Six weeks post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Related trials for Hysterectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
Active, not recruitingPhase 2
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
Post Operative Analgesia
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HominisTM Surgical System in people with Hysterectomy, run by Memic Innovative Surgery at 2 sites in 2 countries.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of conversion (time frame: Intra Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.