Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358365
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2024-01-15
Brief Title:
Enhancing Fluid Transfer Through the Skin by Increased Sweat Rate on Hemodialysis Patients
Sponsor:
AquaPass Medical Ltd
Organization:
AquaPass Medical Ltd
Study Overview
Official Title:
Evaluation of the Safety Performance of the Aquapass -Medical Device for Enhancing Fluid Transfer Through the Skin by Increased Sweat Rate on Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients by increasing fluid loss via the skin
Detailed Description:
This study requires several investigational tests exams and data collection procedures to be performed by the participants These procedures are listed in abbreviated format in the Schedule of AssessmentsActivities table The final eligibility of the trial will be confirmed after a 2-hour acclimatization session The trial-specific procedures must not be performed until the participant has signed a written informed consent form which has been approved by the sites Institutional Review Board
The investigator or designee who is trained in the clinical investigation plan will explain the nature and scope of the trial to the participant They will also discuss the potential risks and benefits of participation and answer any questions the participant may have If the participant agrees to participate they must sign the informed consent form The investigatordesignee must also sign the form before the participant can be enrolled in the trial Any additional persons required by the sites Institutional Review Board to sign the informed consent form must also comply
Each participants study duration will be approximately 8 weeks The study duration will be identical for all participants as follows
Screening Period This period will last up to 7 days during which time the participants eligibility for the trial will be determined
Observation Period This period will last 3 weeks during which the participant will come to the medical study center for weekly assessments
Procedure Period This period will last 4 weeks during which time the participant will undergo 2-3 procedures with the AquaPass device each week These procedures will be in addition to their regular hemodialysis treatment The participant will undergo 2 procedures during the weekend and each procedure will last 3-8 hours
Follow-Up This period will last 71 days from the last procedure During this period the participants health status will be monitored
In summary the study requires participants to undergo several investigational tests exams and data collection procedures The study duration for each participant will be approximately 8 weeks during which time they will undergo a screening period observation period procedure period and follow-up period All participants must provide written informed consent before any trial-specific procedures can be performed
The investigator or designee who is trained in the clinical investigation plan will explain the nature and scope of the trial to the participant They will also discuss the potential risks and benefits of participation and answer any questions the participant may have If the participant agrees to participate they must sign the informed consent form The investigatordesignee must also sign the form before the participant can be enrolled in the trial Any additional persons required by the sites Institutional Review Board to sign the informed consent form must also comply
Each participants study duration will be approximately 8 weeks The study duration will be identical for all participants as follows
Screening Period This period will last up to 7 days during which time the participants eligibility for the trial will be determined
Observation Period This period will last 3 weeks during which the participant will come to the medical study center for weekly assessments
Procedure Period This period will last 4 weeks during which time the participant will undergo 2-3 procedures with the AquaPass device each week These procedures will be in addition to their regular hemodialysis treatment The participant will undergo 2 procedures during the weekend and each procedure will last 3-8 hours
Follow-Up This period will last 71 days from the last procedure During this period the participants health status will be monitored
In summary the study requires participants to undergo several investigational tests exams and data collection procedures The study duration for each participant will be approximately 8 weeks during which time they will undergo a screening period observation period procedure period and follow-up period All participants must provide written informed consent before any trial-specific procedures can be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None