Autopsy report · NCT03802656

Vertebral Body Tethering Treatment for Idiopathic Scoliosis

“Device is no longer investigational. It has been approved by the FDA as an HUD under HDE H190005.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 5 months before it started.
• Ran for about 6 months before it stopped.
• 2 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Ochsner Health System

Sponsor type

University, hospital or other

Conditions

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Disease; Adolescent Idiopathic Scoliosis

Interventions

Anterior Vertebral Body Tethering

Participants

2

Sites

1

Countries

United States

Trials that died the same way

• Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure
  “Sponsor no longer pursuing regulatory approval of investigational device” (59% match in meaning)
• Electrical Impedence Tomography With ENLIGHT2100
  “Device received FDA approval” (56% match in meaning)
• Functional Microarray Augmentation of Skin Treatment With Lidocaine
  “The device is undergoing further study in China, per FDA requirements.” (56% 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.