NCT02668978

Brief Summary

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."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

3.5 years

First QC Date

January 27, 2016

Last Update Submit

August 31, 2019

Conditions

LUNG DISEASES

Keywords

lung surgeryair leakprevention

Outcome Measures

Primary Outcomes (1)

  • Duration of postoperative air leaks

    Duration of postoperative lung air leaks expressed in hours

    Within first 30 postoperative days

Study Arms (2)

Hemopatch™

EXPERIMENTAL

Hemopatch™ sealing hemostat

Device: Hemopatch™ Sealing Hemostat

Control

ACTIVE COMPARATOR

Standard surgical technique

Procedure: Standard surgical technique

Interventions

Hemopatch™ Sealing HemostatDEVICE

Hemopatch™ application over lung resection areas

Hemopatch™
Standard surgical techniquePROCEDURE

Lung resuturing or restapling

Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quirónsalud Madrid University Hospital

Pozuelo de Alarcón, Madrid, 280222, Spain

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief of Thoracic Surgery

Study Record Dates

First Submitted

January 27, 2016

First Posted

January 29, 2016

Study Start

March 1, 2016

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

September 4, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)