Autopsy report · NCT00577226

Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine

“IRB has requested additional information regarding IDE”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 years 8 months after it had already started.
• Ran for about 10 years before it stopped.
• 50 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Sponsor

Arkansas Children's Hospital Research Institute

Sponsor type

University, hospital or other

Conditions

Scoliosis

Participants

50

Sites

1

Countries

United States

Trials that died the same way

• Antenatal Development Evaluated Prospectively
  “Not IRB approved” (59% match in meaning)
• A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Liver Transplant Recipients
  “Merged IRB study created” (58% match in meaning)
• Fatty Liver Study in Patients With Type II Diabetes
  “IRB withheld the data due to inadequate supporting documentation” (57% match in meaning)
• Effect of Vascular Endothelial Growth Factor Blockers on Aqueous Humor Dynamics
  “Limited resources; IRB approval was not maintained” (57% match in meaning)
• Photoacoustic Endoscopy in Endometrial Cancer
  “Need to obtain IDE prior to commencement of study” (55% 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.