Connected Catheter - Safety and Effectiveness Study

NCT04059159 | Terminated Results DMC FDA Device

• 1 other identifier: CIP-0002 (formerly ES-NIH-01)
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Neurogenic Bladder; Urinary Retention; Urologic Diseases

Keywords

catheter; Spinal Cord Injury (SCI)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Device Related Serious Adverse Events

  Rate of participants treated with the Connected Catheter reported with a serious device related adverse event

  0 - 49 days

Secondary Outcomes (2)

• Number of Participants With UTI (Occurrence Rate)

  0 - 49 days

• Number of Participants With Lower Urinary Tract Injury

  0 - 40 days

Study Arms (1)

Connected Catheter Users

EXPERIMENTAL

Device: Connected Catheter

Interventions

Connected Catheter DEVICE

Patients will use the Connected Catheter to empty the bladder during the course of treatment.

Connected Catheter Users

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Device is currently only designed for use by males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males age ≥ 18 with clinical diagnosis of significant urinary retention
• Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
• Must have stable urinary management history as determined by the investigator OR:
• Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity \> 200mL without uninhibited bladder contractions)
• Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for Use (IFU).

You may not qualify if:

• Active symptomatic urinary tract infection, as defined in this clinical investigation protocol (subjects may receive the device after UTI has been treated)
• Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
• Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia
• Significant intermittent urinary incontinence (between catheterizations)
• Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injection)
• Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)
• Urinary tract inflammation or neoplasm
• Urinary fistula
• Bladder diverticulum (outpouching) \> 5cm in size
• Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
• Impaired kidney function or renal failure
• Active gross hematuria
• Active urethritis
• Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
• Any unsuitable comorbidities as determined by the Investigator or complications related to use of certain medications

Sponsors & Collaborators

• Spinal Singularity: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Rancho Los Amigos Rehabiliation Hospital

Downey, California, 90242, United States

Location

UC San Diego

San Diego, California, 92093, United States

Location

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Retention; Urologic Diseases; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

single arm, small sample size

Results Point of Contact

• Title: Derek Herrera
• Organization: Spinal Singularity

dherrera@urodevmedical.com

949-436-7974

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: October 1, 2020
• Primary Completion: March 24, 2021
• Study Completion: April 7, 2021
• Last Updated: January 20, 2023
• Results First Posted: January 20, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)