NCT01834612

Brief Summary

To determine if a manual blood loss can be detected using the non-invasive blood monitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

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

January 7, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

April 15, 2013

Last Update Submit

July 14, 2021

Conditions

Blood Loss

Keywords

blood loss, hemorrhage, hemorrhagic shcok

Outcome Measures

Primary Outcomes (1)

  • Detect change in blood volume by non-invasive monitoring during whole blood draw

    4 months

Study Arms (2)

Blood draw

ACTIVE COMPARATOR

CM1500 with blood draw

Device: CM1500

No blood draw

SHAM COMPARATOR

CM 1500 with no blood draw

Device: CM1500

Interventions

CM1500DEVICE

blood volume monitor

Blood drawNo blood draw

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteer
  • between 18 to 50 years of age
  • weight between 157 to 220 lbs

You may not qualify if:

  • unstable or untreated cardia disease
  • alcohol consumption in 24 hours prior to screening
  • tobacco use in 4 hours prior to screening
  • pregnancy
  • infection
  • Hemoglobin \< 12.5 g/dL at time of procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chris Galloway, MD

    Davita Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

January 7, 2013

Primary Completion

March 11, 2013

Study Completion

March 11, 2013

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

US(1)