Autopsy report · NCT00748124

PleuraSeal Pivotal Study (US)

“Interim analysis results were not supportive of primary endpoint”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 2 years 8 months before it stopped.
• 230 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Integra LifeSciences Corporation

Sponsor type

Industry

Conditions

Open Thoracotomy

Interventions

PleuraSeal Sealant System; Standard Tissue Closure Techniques

Participants

230

Sites

1

Countries

United States

Trials that died the same way

• A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer
  “At the time of the primary analysis, results did not meet the primary endpoint” (83% match in meaning)
• Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.
  “Primary endpoint measure not suitable for evaluation” (72% match in meaning)
• OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
  “The primary endpoint was not achieved in the study.” (72% match in meaning)
• Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)
  “The study was terminated as its Part A did not meet the primary endpoint.” (70% match in meaning)
• A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments
  “The study did not meet the primary endpoint.” (69% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.