Clinical trial NCT04109989: Clinical Assessment - HominisTM Surgical System
Official title: Clinical Assessment - HominisTM Surgical System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hysterectomy
Lead sponsor: Memic Innovative Surgery
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of conversion
timeFrame: Intra Operative
Secondary outcomes:
measure: Intra-operative & post-operative procedural outcomes
timeFrame: Intra-operative and six weeks post procedure
measure: Intra-operative & post-operative procedural outcomes
timeFrame: Intra-operative & six weeks post procedure
measure: Intra-operative & post-operative procedural outcomes
timeFrame: Intra-operative & six weeks post procedure
measure: Intra-operative & post-operative procedural outcomes
timeFrame: Intra-operative & six weeks post procedure
measure: Intra-operative procedural outcomes
timeFrame: Intra-operative
measure: Intra-operative & post-operative procedural outcomes
timeFrame: Intra-operative & six weeks post procedure
measure: Intra-operative procedural outcomes
timeFrame: Intra-operative
measure: Intra-operative & post-operative procedural outcomes
timeFrame: Intra-operative & six weeks post procedure
measure: Post-operative procedural outcomes
timeFrame: Six weeks post procedure
measure: Post-operative procedural outcomes
timeFrame: Six weeks post procedure
measure: Post-operative procedural outcomes
timeFrame: Six weeks post procedure
measure: Vaginal tissue healing
timeFrame: Six weeks post procedure
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Haifa
country: Israel
facility: Rambam Hospital
Study officials:
References: