Autopsy report · NCT03381677

Pedicle Osteotomy for Stenosis Trial

“In light of the ongoing COVID-19 pandemic and its impact on clinical trials”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month after it had already started.
• Suspended: paused, and may or may not restart.
• 344 participants planned (an estimate, not an actual count).

Vital statistics

Status

Suspended

Phase

Na

Sponsor

Innovative Surgical Designs

Sponsor type

Industry

Conditions

Lumbar Spinal Stenosis; Spondylolisthesis, Grade 1; Neurogenic Claudication

Interventions

Pedicle Lengthening Osteotomy with Altum® Device; Control

Participants

344 (planned, not actual)

Sites

1

Countries

United States

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  “Covid-19 Pandemic prevented this study from beginning” (80% match in meaning)
• Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients
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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.