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NCT05330598 · ClinicalTrials.gov registry record · NA

Evaluation of the Safety and Clinical Performance of the Connected Catheter Study

A NA study, sponsored by Spinal Singularity.

Terminated
Registry status
NA
Development phase
26
Enrollment target

NCT05330598: Clinical Trial NA study, sponsored by Spinal Singularity.

NCT05330598 is a NA study that was terminated before completion, run by Spinal Singularity. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05330598, a NA study, was terminated before completion, sponsored by Spinal Singularity.

TERMINATED
Registry status
NA
Development phase
26 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use. The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.

Primary Outcome

PVR Responder Rate, defined as either: * Less than or equal to 50mL OR * Equal to or less than their baseline PVR when using SOC catheters The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders.

Interventions

  • DEVICE Connected Catheter

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2022-01-27
Est. Completion 2024-02-01
Phase NA
Spinal Singularity

5 total trials

Why NCT05330598 stopped before completion

NCT05330598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Connected Catheter is the first listed.

NCT05330598 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05330598 about?

NCT05330598 is a clinical study titled "Evaluation of the Safety and Clinical Performance of the Connected Catheter Study". The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use. The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for i...

What is the current status of trial NCT05330598?

This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2022-01-27. Estimated completion is 2024-02-01.

What interventions are being tested in trial NCT05330598?

The interventions under investigation include: Connected Catheter (DEVICE).

Who is sponsoring clinical trial NCT05330598?

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

How this trial's enrollment target compares

Where NCT05330598's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 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 NCT05330598, the US trial registry maintained by the National Library of Medicine. NCT05330598 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.