Mirus LigatingClip applier and Myclip™ Polymer Ligating clip applier

Not Applicable

• Conditions: Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

• Registration Number: CTRI/2024/03/063960
• Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients who have been treated with Ligating Clip and Clip Applier.

Exclusion Criteria

1. Since this is retrospective study there is no specific Exclusion Criteria for this study

2. A list of all the potential patients that have been treated with Ligating Clips and Clip Applier and will be selected for the study.

3.Waiver for written informed consent will be requested to the Institutional Ethics Committee as this is a retrospective analysis without any alteration in patient management.

4. Baseline, procedural and follow-up data will be

collected and reported in the CRF.

5. Patients’ identity will be kept confidential and the data will be collected in the form of redacted documents.

6. The data collected on CRF will be taken up for

analysis and evaluation.

7. Analysis will be done through descriptive and inferential statistics as per requirement.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reoperation : To correct the complications of a previous operation.Timepoint: Through 05 year <br/ ><br>Follow-up

Secondary Outcome Measures

Name	Time	Method
1. Duration of surgery <br/ ><br>2.post-operative complications such as Abscess, <br/ ><br>Wound Infection, Pain, Bleeding and anastomotic <br/ ><br>stenosis <br/ ><br>3.Length of Hospital Stay <br/ ><br>4. Surgical site infection <br/ ><br>5. Any malfunction or failure in device or migration of <br/ ><br>clips <br/ ><br>6. Adverse events related to device <br/ ><br>7. Overall HandlingTimepoint: 1. Time Frame: At the time of <br/ ><br>Surgery <br/ ><br>2.Time Frame: Through 12 months <br/ ><br>3.Time Frame: At discharge <br/ ><br>4. Time Frame: Through 05 <br/ ><br>years <br/ ><br>5. Time Frame: Through 05 years <br/ ><br>6. Time Frame: Through 05 years <br/ ><br>7. Ligating Clips and Ligating Clip Applier <br/ ><br>