Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07762469

Diagnostic Performance of a Flexible Penile Monitoring System for ED

Sponsor: Bin Xu

View on ClinicalTrials.gov

Summary

This study aims to evaluate the diagnostic performance of a novel intelligent flexible penile monitoring system for erectile dysfunction (ED). The current gold standard, RigiScan Plus, often causes discomfort and disrupts sleep due to its mechanical rings, leading to potential "first-night effect" biases. This research utilizes a prospective crossover design to compare the accuracy of the new flexible system with RigiScan in measuring peak rigidity and tumescence. A total of 60 participants (30 ED patients and 30 healthy volunteers) will be enrolled. The study expects to confirm that the flexible system provides highly accurate diagnostic data while significantly improving patient comfort and maintaining natural sleep structures.

Official title: Diagnostic Performance Evaluation and Clinical Translation Research of a New Intelligent Flexible Penile Monitoring System for Erectile Dysfunction

Key Details

Gender

MALE

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-08-01

Completion Date

2028-02-01

Last Updated

2026-08-13

Healthy Volunteers

Yes

Interventions

DEVICE

Intelligent Flexible Penile Monitoring System

A novel, ultra-thin (\<0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.

DEVICE

RigiScan Plus

RigiScan Plus

Locations (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China