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Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction

NCT05714488 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-01-10

No results posted yet for this study

Summary

The Investigators will study a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual \> 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual \<75 cc.

Conditions

  • Urinary Retention

Interventions

DEVICE

blue halo coil catheter

device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter

Sponsors & Collaborators

  • Blue Halo Biomedical, LLC

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-09-01
Completion
2024-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714488 on ClinicalTrials.gov