Health Condition 1: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 The subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form. 2 In the case of a subject and LAR being illiterate, a literate impartial witness is required during consenting. 3 If the subject is not able to write on behalf of the subject, the subjects LAR (Legally acceptable representative) can fill out the informed consent. 4 The subject is willing and able to comply with postoperative scheduled clinical evaluations. 5 Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. 6 Subject must be treated with MIRUS™ LIGATING CLIP. 7 The subject must receive treatment for securely gripping the vessel or tissue to provide complete occlusion atraumatically
Exclusion criteria
Exclusion criteria: 1 Without informed consent, the subject is not eligible for the study. 2. Patients undergoing fallopian tube ligation or renal artery ligation are not eligible for the use of MIRUS™ LIGATING CLIP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Rate of slippage or movement of the clip in relationship to the total number of used clips 2.Adverse events 3.Re-admission 4.Re-operation 5.Proportion of blood loss 6. Device failure Timepoint: 1.Time Frame: Intraoperatively 2.Time Frame: Intra-operative, discharge, 07 days, 30 days, 3 months, 6 months, 1 year, 3 years, 5 years 3. Time Frame: 30 days, 6 months, 1 year, 3 years, 5 years 4. 07 days, 30 days, 6 months, 1 year, 3 years, 5 years 5. Time Frame: Intra-operative and postoperative 6. Time Frame: Intra-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surgical site infection 2.Clip migration 3.Total operative time 4.Handling parameters 5. Adverse events associated with devicesTimepoint: 1.Time Frame: 07 days, 30 days, 3 months, 6 months, 1 year, 3 years, 5 years 2. Time Frame: Postoperative, 07 days, 15 days, 30 days, 3 months, 6 months, 1 year 3. Time Frame: Intra-operatively 4. Time Frame: Intra-operatively 5. Time frame:Intra Operative and postoperative, 15 days, 30 days, 3 months, 6 months, 1 year | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed