NCT02902627

Brief Summary

l'ANI (Analgesia Nociception Index The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

4 years

First QC Date

September 13, 2016

Last Update Submit

February 20, 2018

Conditions

PainCancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of the ANI parameter with the VAS

    4 hours

Study Arms (1)

Metastatic cancer

EXPERIMENTAL
Device: Non Invasive Monitoring Device (ANI)

Interventions

Non Invasive Monitoring Device (ANI)DEVICE

Pain measure by ANI monitor and with visual analogical scale

Metastatic cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 18 years, -no legal protection, -
  • life expectancy is considered over 3-months
  • not receiving of béta-blocking,
  • Having a rhythm sinusal without extrasystole
  • benefiting from a coverage by a social security system

You may not qualify if:

  • Pace-Maker
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

PainNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Fischler

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 16, 2016

Study Start

August 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)