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Versius Clinical Study

Phase 2
Conditions
Health Condition 1: K80- CholelithiasisHealth Condition 2: K35-K38- Diseases of appendixHealth Condition 3: N88- Other noninflammatory disorders ofcervix uteriHealth Condition 4: N70- Salpingitis and oophoritis
Registration Number
CTRI/2019/02/017872
Lead Sponsor
CMR Surgical Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Patient deemed suitable for at least one of the surgical procedures using Versius

2. Patients (or appropriate legal representatives) able to provide written and audio-visual informed consent to participate in the study

3. Male or female, aged between 18 and 65 years old

4. If female of childbearing potential, must not be pregnant and agree to not become pregnant for the duration of the study.

Exclusion Criteria

1. Patient participation in an investigational clinical study within 30 days before screening

2. Inability to provide informed consent

3. Uncontrolled hypertension and/or diabetes mellitus

4. Patients who fall into New York Heart Association (NYHA) Class III or IV (Appendix B)

5. Incidence of metastases, regional and/or distant

6. History of chronic alcohol or drug abuse

7. Chronic renal failure or on dialysis

8. Significant medical history or immunocompromised

9. Subjects with any other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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