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AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study

NCT06364865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 161

Last updated 2026-05-11

No results posted yet for this study

Summary

This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

Conditions

  • Prostate
  • Gall Bladder Disease
  • Bile Duct Diseases
  • Acute Cholecystitis
  • Kidney
  • Liver
  • Appendix
  • Spleen Disease

Interventions

DEVICE

laparoscopic procedure

Not applicable, subject requiring procedure will have a laparoscopic procedure performed according to the institutions standard of care procedures. There are no clinical procedures performed on the subject as part of this registry study. Surgeon will answer questionnaires regarding use of the device upon completion of the laparoscopic procedure.

Sponsors & Collaborators

  • Teleflex

    lead INDUSTRY

Principal Investigators

  • Tatiana A Puga, BS · Teleflex Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2025-02-27
Completion
2025-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06364865 on ClinicalTrials.gov