A Phase II Prospective, Single Blinded, Randomized Trial... | NCT02364791

Studies
A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

NCT02364791

Sponsor

National Cancer Institute, Naples

Status

Unknown status

Last Update Posted

Mar 24, 2023Actual

Enrollment

120Estimated

Phase

Phase 2

Conditions

Thoracic Surgery Lung
Post-operative Thoracic Air Leak

Interventions

standard techniques used to achieve air leak control
Hemopatch

Countries

Italy

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

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Feb 10, 2015

First Submission Date that Met QC Criteria

Feb 10, 2015

First Posted Date

Feb 18, 2015Estimated

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

Mar 23, 2023

Last Update Posted Date

Mar 24, 2023Actual

Name	Class
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	OTHER
Istituto Clinico Humanitas	OTHER
European Institute of Oncology	OTHER
Regina Elena Cancer Institute

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard treatment	Active Comparator	standard techniques to achieve air leak control after complex thoracic surgical procedures	Device: standard techniques used to achieve air leak control
standard treatment plus hemopatch	Experimental	the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures	Device: standard techniques used to achieve air leak control Device: Hemopatch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard techniques used to achieve air leak control	Device		standard treatment standard treatment plus hemopatch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of days from time of extubation to time of drainage tube removal		up to 7 days

Secondary Outcomes

Measure	Description	Time Frame
number of days to end of air leak	air leak measure are recorded every 6 hours	up to 7 days
worst grade toxicity per patient	according to Common Terminology Criteria for Adverse Events version 4.0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years
High risk of prolonged air leak due to at least one of the following reasons:
- Preoperative FEV1<80%
- DLco < 80%
- LVRS (lung volume reduction surgery o pneumoplastica riduttiva)
- Anticipation of intraoperative adhesions (ie, redo surgery)
- Previous induction chemotherapy for locally advanced NSCLC
- Chronic steroid use
- Pleural mesothelioma
Candidate to one of the following major thoracic surgical intervention:
- Decortication
- Reintervention on the same side of the previous intervention
- Segmentectomy
- Lobectomy with incomplete fissures on CT scan
Written informed consent.

Exclusion Criteria:

Pregnancy or breast-feeding
Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
Known hypersensitivity to bovine proteins or brilliant blue (FD&C Blue No.1)

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

Name	Affiliation	Role
Gaetano Rocco, MD, FRCSEd	National Cancer Institute, Naples	Principal Investigator
Francesco Perrone, MD, PhD	National Cancer Institute, Naples	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS		Naples			Italy