Health Status of Workers in Photocopier Units | NCT01267799

Studies
Health Status of Workers in Photocopier Units

NCT01267799

Sponsor

Avinashilingam Deemed University

Status

Completed

Last Update Posted

Jun 29, 2017Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Exposure to Photocopiers on a Professional Basis

Interventions

Not provided

Countries

India

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

Jun 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

Jul 2011Actual

Primary Completion Date

Jul 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Dec 28, 2010

First Submission Date that Met QC Criteria

Dec 28, 2010

First Posted Date

Dec 29, 2010Estimated

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

Jun 28, 2017

Last Update Posted Date

Jun 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Photocopiers are indispensable in today's working environment. However, photocopiers emit a number of harmful chemicals during their operation. Photocopier toners also contain a number of potentially toxic substances. Chronic exposure to these substances may compromise the health of photocopier operators. This study is aimed to understand if chronic exposure to photocopier emissions is harmful to human health.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess if photocopier emissions are toxic to human health		2 years

Secondary Outcomes

Measure	Description	Time Frame
To assess the best biomarker for pulmonary damage in serum		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exposure to photocopier emissions for minimum 2 years professionally

Exclusion Criteria:

Any clinical abnormality

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

exposure to photocopier emissions

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeyanthi G P, Ph.D	Avinashilingam Deemed University for Women	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avinashilingam Deemed University for Women		Coimbatore	Tamil Nadu	641 043	India
Avinashilingam Deemed University

Label	Type	Description	Intervention Names
photocopier exposure
control