NCT06597604

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

September 12, 2024

Last Update Submit

January 30, 2025

Conditions

Lung Surgery

Keywords

Lung surgeryTenaTacGelatin PatchSealantPALPulmonary Air LeakLobectomy

Outcome Measures

Primary Outcomes (1)

  • To compare the effectiveness of the TenaTac® patch on the duration of thoracic drainage for each patient (regardless of their degree of emphysema) compared to sealing devices routinely used by thoracic surgeons for the same indication

    Assess the effectiveness of the TenaTac® patch in terms of duration of thoracic drainage, compared with sealing devices routinely used by thoracic surgeons for the same indication.

    4 weeks

Secondary Outcomes (3)

  • To assess the effectiveness of the TenaTac® patch in preventing postoperative air leaks throughout the hospital stay, and more specifically in PALs (beyond the 5th day).

    4 weeks

  • Effectiveness of the TenaTac® patch in reducing hospital stay

    4 weeks

  • Effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications

    4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Thoracic Surgeons will apply the experimental device TenaTac® after major lung resection

Device: Intraoperative use of TenaTac in lung surgery

Control Group

ACTIVE COMPARATOR

Thoracic Surgeons will apply other (usual) sealing device after major lung resection

Device: Intraoperative use of usual sealant in lung surgery

Interventions

Intraoperative use of TenaTac in lung surgeryDEVICE

Use of innovative medical device : TenaTac

Experimental Group
Intraoperative use of usual sealant in lung surgeryDEVICE

Use of the usual scealant as a control

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized in the thoracic surgery departments of the investigating centers, for elective surgery,
  • Lobectomy surgery requiring the use of a sealing agent,
  • Adult patients (\>18 years),
  • Patients who have given written consent to participate in the study,
  • Patients registered within the social security insurance in France.

You may not qualify if:

  • Patients hospitalized in emergency,
  • Patients with gelatin allergy,
  • Patients undergoing other biomedical research likely to interfere with the evaluation criteria of this study
  • Patients under tutorship and/or curatorship,
  • Patients unable to follow the planned post-operative follow-up,
  • Patients whose life expectancy is less than 1 year,
  • Pregnant or breast-feeding patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Robert Schuman_Groupe UNEOS

Metz, Grand Est, 57000, France

Location

Centre Hospitalier de la Côte Basque (Bayonne)

Bayonne, 64100, France

Location

MeSH Terms

Interventions

Pulmonary Surgical Procedures

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Alessandro ORSINI, MD

    Hôpitaux Privés de Metz, Groupe UNEOS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofiane Saada, PhD

CONTACT

+33357843376sofiane.saada@uneos.fr

Alessandro ORSINI, MD

CONTACT

+33357842227alessandro.orsini@uneos.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Data collected throughout the trial used in the results publication will be shared with other researchers

Locations

FR(2)