AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

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  Not stated: Registered after enrolment began (about 801 days after the recorded start)First posted 2024-04-22; recorded start 2022-02-11
• ✓
  Present: Has a defined primary outcomeA primary outcome measure is listed in the record
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  Present: The primary outcome states a time frameThe primary outcome measure records a time frame
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  Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
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  Not stated: Whether there is a comparison group is not stated in the registry recordThe record does not describe the study arms
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  Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
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  Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
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  Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
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  Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
• ✓
  Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
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  Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Cordio Medical)
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  Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

• The record lists 1 condition.
• Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1