Study Stopped
Interim analysis results were not supportive of primary endpoint
PleuraSeal Pivotal Study (US)
A Prospective Multicenter Randomized Clinical Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
1 other identifier
interventional
230
1 country
1
Brief Summary
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 4, 2008
CompletedFirst Posted
Study publicly available on registry
September 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedSeptember 11, 2014
September 1, 2014
2.1 years
September 4, 2008
September 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.
75 days
Study Arms (2)
PleuraSeal Sealant Device
EXPERIMENTALControl
OTHERInterventions
Lung Sealant Device + standard tissue closing techniques (sutures/staples)
Standard tissue closure techniques (sutures/ staples) alone
Eligibility Criteria
You may qualify if:
- Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Confluent Surgical
Bedford, Massachusetts, 01730, United States
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2008
First Posted
September 8, 2008
Study Start
August 1, 2008
Primary Completion
September 1, 2010
Study Completion
April 1, 2011
Last Updated
September 11, 2014
Record last verified: 2014-09