NCT02364791

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

9.8 years

First QC Date

February 10, 2015

Last Update Submit

March 23, 2023

Conditions

Thoracic Surgery LungPost-operative Thoracic Air Leak

Keywords

pulmonary resectionchest tubesegmentectomylobectomy

Outcome Measures

Primary Outcomes (1)

  • number of days from time of extubation to time of drainage tube removal

    up to 7 days

Secondary Outcomes (4)

  • number of days to end of air leak

    up to 7 days

  • worst grade toxicity per patient

    up to 6 weeks

  • change in quality of life

    baseline, one week, one month

  • number of days from surgical intervention to patient discharge

    up to 2 weeks

Study Arms (2)

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 controlDevice: Hemopatch

Interventions

standard techniques used to achieve air leak controlDEVICE
standard treatmentstandard treatment plus hemopatch
HemopatchDEVICE
Also known as: sealing hemostat
standard treatment plus hemopatch

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS

Napoli, Italy

Location

Study Officials

  • Gaetano Rocco, MD, FRCSEd

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR

  • Francesco Perrone, MD, PhD

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

IT(1)