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NCT03601936 · ClinicalTrials.gov registry record · NA

User Testing of the Evivo Screening Test

A NA study, sponsored by Evolve BioSystems.

Terminated
Registry status
NA
Development phase
231
Enrollment target

NCT03601936: Clinical Trial NA study, sponsored by Evolve BioSystems.

NCT03601936 is a NA study that was terminated before completion, run by Evolve BioSystems. The registered enrollment target is 231 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03601936, a NA study, was terminated before completion, sponsored by Evolve BioSystems.

TERMINATED
Registry status
NA
Development phase
231 participants
Enrollment target

Study Summary

The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.

Primary Outcome

The primary objective of this CLIA Waiver User Testing study is to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test in a setting that closely resembles the conditions of intended use, specifically the circumstances of sample collection, the location of test sites, and the potential operators.

Interventions

  • DEVICE Evivo Infant Gut Bifidobacterium Screening Test

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2018-08-01
Est. Completion 2019-04-24
Phase NA
Evolve BioSystems

5 total trials

Why NCT03601936 stopped before completion

NCT03601936 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 1 intervention - of which Evivo Infant Gut Bifidobacterium Screening Test is the first listed.

NCT03601936 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03601936 about?

NCT03601936 is a clinical study titled "User Testing of the Evivo Screening Test". The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.

What is the current status of trial NCT03601936?

This trial is currently terminated. It is a NA study. The enrollment target is 231 participants. The study started on 2018-08-01. Estimated completion is 2019-04-24.

What interventions are being tested in trial NCT03601936?

The interventions under investigation include: Evivo Infant Gut Bifidobacterium Screening Test (DEVICE).

Who is sponsoring clinical trial NCT03601936?

This trial is sponsored by Evolve BioSystems, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03601936's enrollment target sits among peer trials

231 465th of 2000 higher than 1,536 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03601936, the US trial registry maintained by the National Library of Medicine. NCT03601936 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.