Autopsy report · NCT01661608

Gastric Restriction Using the EndoSurgical Operating System

“FDA indicated study should have had prior IDE submission \& approval”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 years 8 months after it had already started.
• Ran for about 1 year 1 month before it stopped.
• 32 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

USGI Medical

Sponsor type

Industry

Conditions

Obesity

Interventions

Using the EOS for gastric restriction

Participants

32

Sites

5

Countries

Mexico, United States

Trials that died the same way

• Intradural Percutaneous Stimulation
  “Unable to obtain FDA IDE approval. Currently working on additional preclinical testing.” (73% match in meaning)
• Perceval S Aortic Heart Valve Study- North America
  “FDA approval” (69% match in meaning)
• Electrical Impedence Tomography With ENLIGHT2100
  “Device received FDA approval” (66% match in meaning)
• The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine
  “Pending FDA approval” (65% match in meaning)
• A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
  “study intervention was approved by the FDA” (65% 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.