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NCT06364865: AE05ML
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
trial testing laparoscopic procedure in Gall Bladder Disease in 161 participants. Enrolling by invitation.
27 February 2025
Quick facts
| Lead sponsor | Teleflex |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 161 |
| Start date | 7 June 2024 |
| Primary completion | 27 February 2025 |
| Estimated completion | 30 August 2025 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- laparoscopic procedure
Conditions studied
- Gall Bladder Disease — all drugs for Gall Bladder Disease →
- Bile Duct Diseases — all drugs for Bile Duct Diseases →
- Acute Cholecystitis — all drugs for Acute Cholecystitis →
- Kidney — all drugs for Kidney →
Sponsor
Teleflex — full company profile →
Who can join
18 and older, any sex, with Gall Bladder Disease or Bile Duct Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06364865
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Teleflex trials
Trials by the same sponsor.
- NCT06604039 — A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices · recruiting
- NCT05702515 — Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study · completed
- NCT05278507 — Comparing Arrow PICC Catheters w/ Arrowga+rd Blue Advanced Protection Performance and Safety to Unprotected PICC's · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06364865 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Teleflex
- Last refreshed: 5 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06364865.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing