Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2021-11-29

Brief Summary

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The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.

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Detailed Description

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Postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock. Monitoring and detecting these fluid changes postoperatively can be complicated, and standard operating procedures vary. The Cardiac Monitor, Model 1500 (CM-1500), uses a personalized approach by non-invasively and simultaneously monitoring five (5) physiological parameters.

Conditions

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Blood Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood Volume Monitoring

Group Type EXPERIMENTAL

CM-1500

Intervention Type DEVICE

Blood volume monitor CM-1500

Interventions

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CM-1500

Blood volume monitor CM-1500

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent
* Ability and willingness to comply with study procedures and duration requirements
* 18 years of age or older
* Undergoing an abdominal or pelvic surgery within the next 10 days

Exclusion Criteria

* Females who are pregnant or breastfeeding
* Participation in other clinical studies involving experimental drugs or devices
* Undergone an amputation of the left upper extremity
* Diagnosed with Dextrocardia
* Subjects who have a Pacemaker

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No