User Testing of the Evivo Screening Test

User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium 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.

Study Overview

• Status: Terminated
• Conditions: Gut Microbiome
• Intervention / Treatment: Device: Evivo Infant Gut Bifidobacterium Screening Test

Detailed Description

This is a prospective, multi-center clinical study of the Evivo Infant Gut Bifidobacterium Screening Test ("Evivo Screening Test").

Lower levels of bifidobacteria in the infant gut have been linked to increased incidence of metabolic and inflammatory disorders. This CLIA Waiver User Testing study is being conducted to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test, which was designed to differentiate between high and low levels of Bifidobacterium in infant stool. This study is intended to confirm the precision of results for this screening test, as well as its ease of use, 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.

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research, Inc.
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Breastfeed Atlanta LLC
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
  • Pennsylvania
    • Swarthmore, Pennsylvania, United States, 19081
      • Swarthmore Pediatrics
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants aged 0-6 months.
• Generally healthy infants.

Exclusion Criteria:

• Infants should not have an acute infection.
• Not intended for use with stool containing meconium.
• Infants with jaundice should not be tested until it has resolved.
• This test should not be used for infants with carbohydrate malabsorption syndrome, which may present with one or more of the following persistent signs: abnormally foul-smelling, mucus-containing, and/or green frothy stools.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Infants less than 6 months of age; The Evivo Infant Gut Bifidobacterium Screening Test study is a single-group interventional study of 600 female and male infants who are less than 6 months of age and generally healthy.	Device: Evivo Infant Gut Bifidobacterium Screening Test; Operators at each test site will collect and test infant stool specimens according to the Evivo Infant Gut Bifidobacterium Screening Test protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens compared to molecular methods (quantitative PCR).	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.	2 - 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of use of the Evivo Screening Test by operators.	Operators will be asked to complete Operator Questionnaires about their experience using the Screening Test. A 5-point Likert scale will be used to measure outcomes (1 for strongly disagree and 5 for strongly agree). Lower values will represent a worse outcome.	2 - 6 weeks

Collaborators and Investigators

• Sponsor: Evolve BioSystems, Inc.
• Investigators: Study Director: Robin Flannery, rflannery@evolvebiosystems.com

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): April 24, 2019
• Study Completion (ACTUAL): April 24, 2019

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: EV-8601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No