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NCT05628415: Stapler

Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema

Completed NA Last updated 21 February 2025
What this trial tests

NA trial testing Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb) in Postoperative Air Leak in 19 participants. Completed in 20 February 2025.

Timeline
15 November 2022
Primary endpoint
20 February 2025
20 February 2025

Quick facts

Lead sponsorUniversity Hospital, Basel, Switzerland
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment19
Start date15 November 2022
Primary completion20 February 2025
Estimated completion20 February 2025
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Postoperative Air Leak or Lung Resection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prolonged air leak is reported in up to 60 to 75% of patients after lung operation in the presence of severe lung emphysema. The effect of the non-powered AEONTM Endostapler as compared to the Echelon FlexTM Powered plus stapler on the volume and duration of air leak and on the time to chest drain removal after lung operation in the presence of severe lung emphysema will be investigated in a randomized, prospective, single-blinded clinical trial.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy of Non-Powered Stapler in Lung Volume Reduction Surgery of Severe Lung Emphysema: A Prospective Randomized Single-Blinded Monocentric Study.
    Macharia-Nimietz EF, Mallaev M, Gecas P, Vujic J, et al · · 2026 · PMID 41787969 · DOI 10.1093/icvts/ivag071

Verify or expand the search:

Other recruiting trials for Postoperative Air Leak

Currently open trials in the same condition.

Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

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Data sources for this page

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/NCT05628415.

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