Autopsy report · NCT07197840

The CHALLENGER Registry

“FDA request pause in study and an IDE application to be submitted”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Suspended: paused, and may or may not restart.
• 100 participants planned (an estimate, not an actual count).

Vital statistics

Status

Suspended

Sponsor

Icahn School of Medicine at Mount Sinai

Sponsor type

University, hospital or other

Conditions

Chronic Subdural Hematoma

Interventions

Numen SILK coil embolization system

Participants

100 (planned, not actual)

Sites

3

Countries

United States

Trials that died the same way

• Gastric Restriction Using the EndoSurgical Operating System
  “FDA indicated study should have had prior IDE submission \& approval” (73% match in meaning)
• Intradural Percutaneous Stimulation
  “Unable to obtain FDA IDE approval. Currently working on additional preclinical testing.” (69% match in meaning)
• A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
  “FDA requested us to stop the study” (67% match in meaning)
• Safety of SP-420 in the Treatment of Transfusional Iron Overload
  “Study is on hold by FDA in the US.” (65% match in meaning)
• The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine
  “Pending FDA approval” (63% 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.