UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053347 |
|---|---|
| Receipt number | R000060870 |
| Scientific Title | MEDLINK FOR ACCESS TO BASIC HEALTH CARE |
| Date of disclosure of the study information | 2024/01/14 |
| Last modified on | 2025/05/25 19:23:47 |
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Basic information
Public title
MEDLINK FOR ACCESS TO BASIC HEALTH CARE
Acronym
MEDLINK
Scientific Title
MEDLINK FOR ACCESS TO BASIC HEALTH CARE
Scientific Title:Acronym
MEDLINK FOR ACCESS TO BASIC HEALTH CARE
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
ACCESS TO BASIC HEALTH CARE
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Anesthesiology | Oral surgery |
| Neurosurgery | Cardiovascular surgery | Plastic surgery |
| Aesthetic surgery | Laboratory medicine | Operative medicine |
| Emergency medicine | Blood transfusion | Intensive care medicine |
| Rehabilitation medicine | Dental medicine | Nursing |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
THE OBJECTIVES OF THIS CLINICAL TRIAL IS TO:
1. DETERMINE IF MEDLINK CAN BE USED TO MEASURE THE PHYSIOLOGICAL PARAMETERS OUTSIDE OF THE HOSPITAL SETTING AND PROVIDE ACCESS TO BASIC HEALTH CARE
2. TO DETERMINE THE SAFTEY OF MEDLINK IN PROVIDNG ACCESS TO BASIC HEALTH CARE FOR INDIVIDUALS
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. IF MEDLINK WAS ABLE TO MEASURE THE FOLLOWING PHSYICOLOGICAL PARAMETERS FOR ANY PATIENT: Electrocardiography (ECG), Blood Pressure, Heart Rate, Blood Glucose, Pulse Rate, Blood Oxygen Saturation (SPO2), Electromyography (EMG) Body Temperature, and Respiratory Data.
Key secondary outcomes
2. IF THE MEDLINK DEVICE PROVED SAFE TO BE UTILIZED IN PROVIDING ACCESS TO BASIC HEALTH CARE FOR INDIVIDUALS.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
THE MEDLINK DEVICE IS GIVEN TO A HEALTHY INDIVIDUAL TO AUTOMATICALLY MEASURE ANY OR ALL OF THE FOLLWING PHYSIOLOGICAL PARAMTERS: Electrocardiography (ECG), Blood Pressure, Heart Rate, Blood Glucose, Pulse Rate, Blood Oxygen Saturation (SPO2), Electromyography (EMG) Body Temperature, and Respiratory Data.
ONCE THAT IS DONE, THE MEASURED PHYSIOLOGICAL DATA IS TRANSMITTED TO THE PATIENT'S OF INDIVIDUAL'S PHYSICIAN ACCORINGDLY THROUGH A WIRELESS INTERNET CONNECTION.
THIS IS THE METHOD USED BY MEDLINK TO PROVIDE ACCESS TO BASIC HEALTH CARE FOR INDIVIDUALS.
THE TRIAL WAS CONDUCTED BY DR. MICHAEL OLAWUYI (olawuyiracettnigerialtd@outlook.com) and DR. MICHAEL OLAWUYI (mgolawuyi@gmail.com) AND THEY RECRUITED 10 PATIENTS FOR THIS CLINICAL TRIAL.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
18-120 YEARS
Key exclusion criteria
NONE
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | MATTHEW |
| Middle name | |
| Last name | OLAWUYI RC14668218 |
Organization
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218
https://www.olawuyiracettnigerialtd.us/
https://www.olawuyiracettnigerialtd.us/rc14668218-12/
Division name
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218, esthero611-wisetag@ieee.org, @esthero611wisetag
Zip code
OX1 2JD
Address
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218, https://www.olawuyiracettnigerialtd.us/
TEL
+2349113767300
esther.olawuyi@olawuyiracettnigerialtd.us
Public contact
Name of contact person
| 1st name | IMUDIA |
| Middle name | DEKONTE |
| Last name | EHANIRE |
Organization
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218,
Division name
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218,
Zip code
OX1 2JD
Address
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218,
TEL
+2349113767300
Homepage URL
https://www.olawuyiracettnigerialtd.us/
esther.olawuyi@olawuyiracettnigerialtd.us
Sponsor or person
Institute
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218
https://www.robotshop.com/collections/vendor-olwuyi-racett-nigeria-ltd
Institute
Department
Personal name
Funding Source
Organization
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218
esther.olawuyi@olawuyiracettnigerialtd.us
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
United Kingdom
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
OLAWUYI RACETT NIGERIA LTD., WELLINGTON SQUARE, OXFORD, OX1 2JD, LONDON, UNITED KINGDOM RC14668218, https://www.olawuyiracettnigerialtd.us/
Address
Community Federal Savings Bank, 89-16 Jamaica Avenue, Woodhaven, NY 11421, USA, https://www.olawuyiracettnigerialtd.us/
Tel
+2349113767300
esther.olawuyi@olawuyiracettnigerialtd.us
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.olawuyiracettnigerialtd.us/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.olawuyiracettnigerialtd.us/
Number of participants that the trial has enrolled
10
Results
MEDLINK WAS SUCESSFULLY USED TO MEASURE THE FOLLOWING PHYSIOLOGICAL PARAMETERS:
1. HEART RATE
2. PULSE RATE
3. ECG
4. SPO2
5. EMG DATA
6. BLOOD GLUCOSE
7. BODY TEMPERATURE
8. FEV1, FVC, FEV1/FVC RATIO
Results date posted
| 2025 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Enrolled 10 Patients Between 10-80 Years.
A MEDLINK Device is given to Each Patien t to take home for 2 Weeks, to measure their Physiological Parameters, and report their Measured Data to their Physicians Once a Day.
Patients Return MEDLINK back to Physicians after two weeks.
Data is Analyzed to Determine Safety and Effectiveness of MEDLINK in Providing Access to Basic Health Care.
Participant flow
10 PATIENTS WERE ENROLLED TO TAKE THEIR PHYSIOLOGICAL PARAMETERS REMOTELY AS A WAY TO PROVIDE ACCESS TO BASIC HEALTH CARE FOR THEM.
ENROLLMENT -> INTERVENTION ALLOCATION -> FOLLOW UP -> DATA ANALYSIS
Adverse events
NONE
Outcome measures
THE TRIAL FOUND MEDLINK TO BE SAFE AND EASY TO USE.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060870
