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Mirus Ligating Clip applier and Myclip™ Polymer Ligating clip applier

A retrospective, multicentre, observational, real-world post-market clinical follow-up study to evaluate the safety & performance of Mirus Ligating clip and Myclip™ Polymer Ligating clip is intended to securely grip the vessel or tissue to provide complete occlusion atraumatically and Mirus Ligating Clip applier and Myclip™ Polymer Ligating clip applier both are use to allows the end user to ligate a wide range of vessels and tissue structures - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/063960
Enrollment
300
Registered
2024-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Reoperation : To correct the complications of a previous operation.Timepoint: Through 05 year Follow-up—

Secondary

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

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026