## Protocol Section
### Identification Module
**NCT ID:** NCT01298479

**Brief Title:** Sayana-Uniject Volumetric Delivery

**Official Title:** Quantitative Determination of the Volume of Suspension Delivered Via the Uniject Delivery System Following Simulated Subcutaneous Injection by Healthcare Professionals Into a Synthetic Subcutaneous Injection Training Device

#### Organization Study ID Info
**ID:** A6791034
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-12-07

**Type:** ACTUAL

**Last Update Submit Date:** 2018-12-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Start Date
**Date:** 2010-05

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2011-02-17
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-16
**Study First Submit QC Date:** 2011-02-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine the volumetric delivery of the Uniject.

**Detailed Description:** Observe subjects deliver the drug None used

### Conditions Module

**Conditions:**

- Volume Delivery

**Keywords:**

- volume delivery

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 25

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects

**Intervention Names:**

- Other: Uniject

**Label:** Group 1

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

**Description:** single use container

**Name:** Uniject

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Weight of drug suspension delivered (estimated by change in mass of the Uniject(TM) delivery system).

**Time Frame:** Visit 1

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Nurses

Exclusion Criteria:

* Non-nurses

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** nurses

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bruxelles

**Country:** Belgium

**Facility:** Pfizer Investigational Site

**Zip:** B-1070

#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here.

**URL:** https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6791034&StudyName=Sayana-Uniject%20Volumetric%20Delivery

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
