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Device
Peezy Device for Asymptomatic Bacteriuria (Peezy-DAB Trial)
Phase 3
Recruiting
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up august 2022-august 2023
Awards & highlights
Peezy-DAB Trial Summary
This trial will compare rates of contaminants in urine collected using a standard method versus the PEEZY device, specifically among pregnant women with different BMI levels.
Who is the study for?
This clinical trial is for pregnant women less than 20 weeks into their pregnancy, over the age of 18, and who speak English. It's not suitable for those with a history of frequent UTIs, urinary tract anomalies or those needing ongoing antibiotics.Check my eligibility
What is being tested?
The study is testing if using the PEEZY urine collection device reduces sample contamination compared to standard clean-catch methods during urine tests in pregnant women, especially focusing on those with different body sizes (BMI above or below 30).See study design
What are the potential side effects?
Since this trial involves a non-invasive urine collection device rather than medication, there are no direct side effects related to drugs. However, discomfort or issues with using the device could potentially occur.
Peezy-DAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ august 2022-august 2023
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~august 2022-august 2023
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urine contamination rates
Secondary outcome measures
Maternal comorbidities and contamination
Peezy-DAB Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: PEEZy collection BMI < 30Experimental Treatment1 Intervention
PEEZY device for urine collection
Group II: PEEZY collection BMI > 30Experimental Treatment1 Intervention
PEEZY device for urine collection
Group III: Clean catch BMI < 30Placebo Group1 Intervention
Standard of care urine collection
Group IV: Clean catch BMI > 30Placebo Group1 Intervention
Standard of care urine collection
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Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,734 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had multiple urinary tract infections in the past.You are currently taking antibiotics and need to continue taking them.You have abnormalities in your urinary tract.
Research Study Groups:
This trial has the following groups:- Group 1: Clean catch BMI < 30
- Group 2: Clean catch BMI > 30
- Group 3: PEEZy collection BMI < 30
- Group 4: PEEZY collection BMI > 30
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Out of how many applicants will this research select participants?
"That is correct, the information available on clinicaltrials.gov supports that this research is actively looking for volunteers. The study was originally posted on August 1st, 2022 and was last updated September 21st, 2022. They are aiming to have 200 people participate from 1 location."
Answered by AI
Has the FDA cleared PEEZY for use with patients who have a BMI above 30?
"PEEZY collection BMI > 30 is estimated to be a 3 on the Power Safety Scale because it is a Phase 3 trial."
Answered by AI
Are there any empty slots in this trial for new participants?
"This study is looking for candidates according to the clinicaltrials.gov website. The study was first posted on 8/1/2022 and was last updated on 9/21/2022."
Answered by AI
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