Healthy Clinical Trial - Home Usage of Conception Kit Instructions

Status Active, not recruiting

Clinical Trial Summary

Patients will use the Conception Kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website: www.conceptionkit.com.

Clinical Trial Description

Patients will be given a Conception Kit and take the Kit home and read the instructions and if needed consult the website. The patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use.

All Components have 510K clearance. This study is a validation of the instructions for use (IFU) only.

OPK Class I Device 21CFR 862.1485, Conception Cap K993953, Pregnancy Test Kit K974059, Semen Collection Device K902936 (21CFR 884.5300),

Conception Kit has CE Marked by GMED. (Certificate 2037)

Conceivex is an ISO 13485: 2003 company ;

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT00326651
Study type	Observational
Source	Conceivex
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	May 2006
Completion date	May 2007

View Details

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