Safety and Acceptability Study of PrePex Device When Remo... | NCT03132285

Studies
Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device

NCT03132285

Sponsor

Ministry of Health, Zambia

Status

Completed

Last Update Posted

Sep 7, 2017Actual

Enrollment

500Actual

Phase

Not Applicable

Conditions

HIV Prevention

Interventions

PrePex

Countries

Zambia

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2017Actual

Primary Completion Date

Apr 22, 2017Actual

Completion Date

Jun 17, 2017Actual

First Submitted Date

Apr 4, 2017

First Submission Date that Met QC Criteria

Apr 24, 2017

First Posted Date

Apr 27, 2017Actual

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

Sep 6, 2017

Last Update Posted Date

Sep 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

Detailed Description

Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex.

Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.

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

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PrePex Day 0 foreskin removal	Other	Day 0 foreskin removal	Device: PrePex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PrePex	Device	Prepex is a non surgical male circumcision device	PrePex Day 0 foreskin removal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of incidents related to the change in procedure	To assess the safety of PrePex device when removing the foreskin shortly after device placement by means of the following parameter: Incidence of Serious Adverse Events, when performed by clinicians and nurses	8 weeks
Acceptability of the changes procedure to patients	To asses the new procedure acceptability for patients using the following measures - Evaluation of pain during foreskin removal Patients willingness to wait for foreskin removal Odour while device is in situ Pain at key time points on Removal visit Discomfort of any type to patients.	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Effect of the change in procedure on circumcision healing time	To assess the circumcision healing time period.	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages - 13 to 49 years
Uncircumcised
Participant wants to be circumcised
Participant assent to the procedure
Legal guardian consent to the procedure for ages 13-18 years
Able to understand the study procedures and requirements
Agrees to abstain from sexual intercourse for 8 weeks after circumcision
Agrees to abstain from masturbation for at least 2 weeks after Removal
Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
Participant able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

Exclusion Criteria:

Legal guardian withholds consent for ages 13-18 years
Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
Participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
Known bleeding / coagulation abnormality, uncontrolled diabetes
Participant that to the opinion of the investigator is not a good candidate
Diabetes Mellitus
HIV Sero-positive

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Uncircumcised males

Minimum Age

13 Years

Maximum Age

49 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Matero Main Clinic		Lusaka	Lusaka Province		Zambia
Dambwa North Clinic

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided