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Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery

NCT06597604 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-02-03

No results posted yet for this study

Summary

Lung surgery remains a high-risk procedure, with serious adverse events that can occur later, including postoperative bleeding or hemothorax, pneumopathy or surgical site infection but also ... per- and post-operative air leaks. Majority the air leaks resolve spontaneously within 48 hours but certain cases persist within several days which known as prolonged air leaks, or PAL. Several safe and effective sealing agents are used to contain and or reduce the intensity and incidence of postoperative air leaks, and the time required for drain removal. This protocol assesses the effectiveness of an innovative gelatin-based medical device named TenaTac® (Selentus Science, UK) in preventing air leak after major lung resection.

Conditions

  • Lung Surgery

Interventions

DEVICE

Intraoperative use of TenaTac in lung surgery

Use of innovative medical device : TenaTac

DEVICE

Intraoperative use of usual sealant in lung surgery

Use of the usual scealant as a control

Sponsors & Collaborators

  • CuraMedrix B.V.

    collaborator UNKNOWN

  • Medical Advices Consulting

    collaborator UNKNOWN

  • Hopitaux Prives de Metz, Groupe UNEOS

    lead OTHER

Principal Investigators

  • Alessandro ORSINI, MD · Hôpitaux Privés de Metz, Groupe UNEOS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • France

Study Locations

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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 NCT06597604 on ClinicalTrials.gov