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SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

Q

Quirón Madrid University Hospital

Status and phase

Completed
Phase 4

Conditions

LUNG DISEASES

Treatments

Procedure: Standard surgical technique
Device: Hemopatch™ Sealing Hemostat

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.

Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients over the age of 18 years who are able to give their informed consent

  • Patients undergoing lung resection surgery for either malignant or benign conditions including:

    • Lobar and sublobar resections
    • Open, video-assisted thoracoscopic or robotic surgeries
    • Diagnostic or therapeutic procedures

Exclusion criteria

  • Traumatic pulmonary contusion or laceration
  • Lung reduction surgery
  • Planned removal of more than 10 lung lesions
  • Pneumonectomy
  • Known hypersensitivity to bovine protein
  • Known hypersensitivity to Brilliant Blue FCF (E133)
  • Presence of active infection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

170 participants in 2 patient groups

Hemopatch™
Experimental group
Description:
Hemopatch™ sealing hemostat
Treatment:
Device: Hemopatch™ Sealing Hemostat
Control
Active Comparator group
Description:
Standard surgical technique
Treatment:
Procedure: Standard surgical technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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