Autopsy report · NCT04115605

A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

“The minimum of enrolled subject defined in the protocol was 180 patients and it was greatly exceeded. Therefore the study was terminated by the sponsor to perform the study analysis.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months after it had already started.
• Ran for about 7 years 1 month before it stopped.
• 598 participants enrolled.
• Results were posted on the registry 3 years 11 months after it ended.

Vital statistics

Status

Terminated

Sponsor

Coloplast A/S

Sponsor type

Industry

Conditions

Urinary Incontinence, Stress

Interventions

Altis Single Incision Sling

Participants

598

Sites

33

Countries

Belgium, France, Germany, Italy, Spain

Trials that died the same way

• A Study to Evaluate the Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Cognitive Function in Clinically Stable Patients With Schizophrenia
  “The study was terminated due to insufficient sample size and protocol compliance issue.” (80% match in meaning)
• The Role of Splinting in Fingertip Injuries
  “Very few subjects were enrolled. Therefore, the study was terminated.” (77% match in meaning)
• Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease
  “This study was terminated due to low participant enrollment.” (77% match in meaning)
• Starting the Conversation
  “The study was terminated due to a small number of study participants.” (77% match in meaning)
• Saracatinib in Treating Patients With Prostate Cancer
  “Per protocol, study was terminated due to low rate of randomized patients.” (77% 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.