Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04109989
Other study ID # MEMIC-5083
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2018
Est. completion date December 30, 2021

Study information

Verified date February 2021
Source Memic Innovative Surgery
Contact Limor Kuznits, B.Sc
Phone +972-54-630-20-12
Email Limor@memicmed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 30, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Female above 18 years of age inclusive. 2. Able to provide written informed consent. 3. 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. 4. Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System. 5. Fit for robotic-assisted transvaginal surgery based on surgeon discretion. 6. Can undergo general anesthesia per anesthesiologist assessment. Exclusion Criteria: 1. 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). 2. Women after pelvic radiation. 3. Women diagnosed with active intra-abdominal malignancy. 4. Women with general condition or illness incompatible for surgery. 5. Women who are pregnant. 6. Unwillingness or inability to follow the procedures outlined in the protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HominisTM Surgical System
Trans-vaginal gynecological procedures

Locations

Country Name City State
Belgium Imelda Hospital Bonheiden
Israel Rambam Hospital Haifa

Sponsors (1)

Lead Sponsor Collaborator
Memic Innovative Surgery

Countries where clinical trial is conducted

Belgium,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of conversion Rate of conversion to open or laparoscopic approach Intra Operative
Secondary Intra-operative & post-operative procedural outcomes Intra-operative & post-operative complications Intra-operative and six weeks post procedure
Secondary Intra-operative & post-operative procedural outcomes adverse events (AE and SAE) Intra-operative & six weeks post procedure
Secondary Intra-operative & post-operative procedural outcomes Bladder injury rate Intra-operative & six weeks post procedure
Secondary Intra-operative & post-operative procedural outcomes Rectal injury rate Intra-operative & six weeks post procedure
Secondary Intra-operative procedural outcomes Operative time Intra-operative
Secondary Intra-operative & post-operative procedural outcomes Transfusion rate Intra-operative & six weeks post procedure
Secondary Intra-operative procedural outcomes Conversion rate (to laparotomy, laparoscopy, other ports used in addition to vaginal and umbilical port). Intra-operative
Secondary Intra-operative & post-operative procedural outcomes Mortality Intra-operative & six weeks post procedure
Secondary Post-operative procedural outcomes Length of hospital stay Six weeks post procedure
Secondary Post-operative procedural outcomes Re-admission rate Six weeks post procedure
Secondary Post-operative procedural outcomes Re-operation rate Six weeks post procedure
Secondary Vaginal tissue healing Vaginal tissue healing will be assessed Six weeks post procedure
See also
  Status Clinical Trial Phase
Recruiting NCT05337566 - Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections N/A
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Recruiting NCT05537727 - Robotic MIS With Dexter
Completed NCT05037383 - Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions N/A
Completed NCT04080323 - Single-dose Vaginal Dinoprostone and Hysterectomy Phase 3
Not yet recruiting NCT06011538 - Web-based Versus Standard Information for Same Day Hysterectomy (WISH) N/A
Completed NCT03187327 - Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology N/A
Terminated NCT00551785 - Surveillance Study of Women Taking Intrinsa® Phase 4
Completed NCT00528177 - Morphine vs. Oxycodone for Postoperative Pain Management Phase 4
Completed NCT03641625 - Effect of SmtO2 Guided Care on PONV (iMODIPONV) N/A
Terminated NCT03500744 - Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery N/A
Recruiting NCT03294343 - Risk-Reducing Surgeries for Hereditary Ovarian Cancer N/A
Completed NCT03610425 - A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
Completed NCT05659303 - Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy
Completed NCT05270447 - Short-Term Effects of Connective Tissue Massage After Hysterectomy N/A
Recruiting NCT05031182 - Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique. N/A
Completed NCT03634306 - Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy N/A
Completed NCT01526668 - Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy N/A
Recruiting NCT05374720 - Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy N/A
Recruiting NCT06039566 - NAC vs Placebo on Opioid Use for Hysterectomy Phase 3