Autopsy report · NCT04644731

Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

“The study was stopped early only due to a business decision to pursue development of a pediatric dedicated device. This decision was not based on any efficacy or safety concerns."”

The sponsor’s own words in the registry.

Life of this trial

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

Vital statistics

Status

Terminated

Sponsor

Nuwellis, Inc.

Sponsor type

Industry

Conditions

Fluid Overload

Interventions

Aquadex™ System

Participants

97

Sites

7

Countries

United States

Trials that died the same way

• Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)
  “Further data are no longer required to support an application for use in pediatric patients. The decision to terminate was not based on any new safety findings” (73% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (72% match in meaning)
• Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
  “The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.” (70% match in meaning)
• Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee
  “The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.” (69% match in meaning)
• Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
  “This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.” (68% 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.