SEALLS (Sealing Evaluation of Air Leaks After Lung Surger... | NCT02668978

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

NCT02668978

Sponsor

Quirón Madrid University Hospital

Status

Completed

Last Update Posted

Sep 4, 2019Actual

Enrollment

170Actual

Phase

Phase 4

Conditions

LUNG DISEASES

Interventions

Hemopatch™ Sealing Hemostat
Standard surgical technique

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

Jan 27, 2016

First Submission Date that Met QC Criteria

Jan 27, 2016

First Posted Date

Jan 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2019

Last Update Posted Date

Sep 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Javier MORADIELLOS, Associate Chief of Thoracic Surgery, Quirón Madrid University HospitalPrincipal Investigator

Lead Sponsor

Quirón Madrid University HospitalOTHER

Collaborators

Name	Class
Baxter BioScience	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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."

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemopatch™	Experimental	Hemopatch™ sealing hemostat	Device: Hemopatch™ Sealing Hemostat
Control	Active Comparator	Standard surgical technique	Procedure: Standard surgical technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemopatch™ Sealing Hemostat	Device	Hemopatch™ application over lung resection areas	Hemopatch™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of postoperative air leaks	Duration of postoperative lung air leaks expressed in hours	Within first 30 postoperative days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quirónsalud Madrid University Hospital		Pozuelo de Alarcón	Madrid	280222	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided