Use of Repris Needle in Bladder Injection | NCT04982120

Studies
Use of Repris Needle in Bladder Injection

NCT04982120

Sponsor

Uro-1 Medical

Status

Unknown status

Last Update Posted

Jul 29, 2021Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Overactive Bladder Syndrome

Interventions

Repris Needle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2018Actual

Primary Completion Date

Jun 14, 2022Estimated

Completion Date

Jul 14, 2022Estimated

First Submitted Date

Jul 15, 2021

First Submission Date that Met QC Criteria

Jul 28, 2021

First Posted Date

Jul 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Jul 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.

Detailed Description

This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Repris Needle	Experimental	Reprise sheath and needle	Device: Repris Needle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Repris Needle	Device	Injection of Botox	Repris Needle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedure Success	Percentage of subjects with successful injection of medication	1 Day of the procedure

Secondary Outcomes

Measure	Description	Time Frame
Patient Tolerance of Injection	Level of pain from use of the needle measured on Likert Scale 1 to 5	1 Day of the procedure
Adverse Events during Procedure	Incidence and Severity of Adverse events associated with the injection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (18 years of age or older)
Able to undergo routine cystoscopy
Willing to provide verbal assessment of her condition within 5 days after the procedure

Exclusion Criteria:

History of urethral strictures
Presence of a suprapubic catheter or tube due to urethral trauma
history of interstitial cystitis
currently being treated for a urinary tract infection (UTI)
gross hematuria present
Known allergy or sensitivity to any component of the medication or solution to be injected during the study
is pregnant, lactating, or with child-bearing potential unable or unwilling to use a reliable form of contraception while participating in the study
cannot empty her bladder on her own and is routinely catheterizing the urethra
unable to read, understand, and/or provide a ranking of pain level during the procedure,
unable or unwilling to provide consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Overactive bladder syndrome is more frequently treated in females than males

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Lawson, PhD	Contact	5102061794		drthomlawson@gmail.com
Jack Snoke	Contact	3365750434		pjsnoke@uro1medical.com

Overall Officials

Name	Affiliation	Role
Thomas Lawson, PhD	Uro-1 Medical	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgia Urology	Recruiting	Cartersville	Georgia	30120	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Patient identification will not be shared

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

Within 7 days after completion of study

Access Criteria

Permission from PI

URL

Not provided