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The MYRAC Electrosurgical Cutting and Coagulation System is a medical device used in ear, nose, and throat (ENT) surgeries to cut or remove soft tissue and to control bleeding by sealing blood vessels

MYRACTM Electrosurgical Cutting and Coagulation System:A prospective, single-arm, multicenter, real-world, open-label, post-market clinical follow-up study to evaluate the safety and performance of MYRACTM Electrosurgical Cutting and Coagulation System - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/103611
Enrollment
88
Registered
2026-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nil: Nil Intervention2: Nil: NIL Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt. Ltd,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants requiring ENT procedures such as ablation, resection, or coagulation of soft tissues (e.g., tonsillectomy, adenoidectomy, nasal turbinate reduction, laryngeal lesion removal, sinus surgery). 2. Participants with bulky larynx lesions, laryngeal lesions, submucosal hypertrophic turbinates, or for hemostasis relating to these conditions. 3. Participants suitable for the application of the MYRACTM device as determined by the surgeon s assessment. 4. Participants with no contraindications to electrosurgical procedures.

Exclusion criteria

Exclusion criteria: 1. Participants with cardiac pacemakers or other electronic implant devices, due to electromagnetic interference risks. 2. Participants with medical conditions or anatomical features making them unsuitable for electrosurgical treatment. 3. Participants with a known hypersensitivity or allergy to materials used in the device. 4. Participants with active infections or skin conditions at the surgical site. 5. Participants who are pregnant or breastfeeding 6. Participants unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
1. Intra-operative Blood Loss (mL) 2. Procedural SuccessTimepoint: 1. Intra-operative 2. Intra-operative—

Secondary

MeasureTime frame
1. Operative Time (minutes) 2. 2. Intra-operative Hemostasis (Modena Bleeding Score MBS) 3. Duration of Hospital Stay (days) 4. Pain Intensity Assessment (Visual Analogue Scale, VAS) 5. Wound/Mucosal Healing (Clinical or Early Healing Score EHS) 6. Ease of UseTimepoint: 1. Time Frame: Intra-operative 2. Time Frame: Intra-operative 3. Time Frame: Post-operative period until discharge 4. Time Frame: pre-procedure (baseline), Through discharge; Day 14, 1 month, 3 month 1 year. 5. Time Frame: Day 14, 1 months, 3 months, 1 year. 6. Time Frame: Intra-operative—

Countries

India

Contacts

Public ContactDr Kiran Kumar Shetty

Meril LIfe Science Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026