Blood LossNCT04706221
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
A study testing CM-1500 in people with Blood Loss, run by Zynex Monitoring Solutions at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Blood Loss
- What is being tested?
- CM-1500
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: Clinical Evaluation of the CM-1500 in Postoperative Abdominal and Pelvic Surgery Patients
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.
Read the detailed description
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
- Blood Loss
- Being tested
- CM-1500
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-1500Device
Blood volume monitor CM-1500
| Study group | Role | What they receive |
|---|---|---|
| Blood Volume Monitoring | Experimental | Not described Receives: Device: CM-1500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Index Change During PACU Stay
The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss relative to the baseline, based on the changes of the individually monitored parameters. Per the device's FDA 510(k) clearance, the RI is computed as the weighted summation of the percent change values (signifying the deviation of each parameter from it's baseline value) for its parameters. Change in RI is calculated by subtracting the initial RI value from the final RI value during monitoring.
Measured: Length of PACU Stay (Range: 46 to 353 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 Jan 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zynex Monitoring Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706221
- Sponsor's protocol ID
- ZMS-1500-2001
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2021
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the CM-1500 in Postoperative Abdominal and Pelvic Surgery Patients
- ClinicalTrials.gov ID
- NCT04706221
- Acronym / sponsor ID
- ZMS-1500-2001
- Conditions
- Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zynex Monitoring SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.
| Arm | Type | Receives |
|---|---|---|
| Blood Volume Monitoring | Experimental | Device: CM-1500 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM-1500Blood volume monitor CM-1500 | Device | Blood Volume Monitoring |
Primary outcome
Relative Index Change During PACU Stay
Time frame: Length of PACU Stay (Range: 46 to 353 minutes)
The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss relative to the baseline, based on the changes of the individually monitored parameters. Per the device's FDA 510(k) clearance, the RI is computed as the weighted summation of the percent change values (signifying the deviation of each parameter from it's baseline value) for its parameters. Change in RI is calculated by subtracting the initial RI value from the final RI value during monitoring.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM-1500 in people with Blood Loss, run by Zynex Monitoring Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Index Change During PACU Stay (time frame: Length of PACU Stay (Range: 46 to 353 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.