The Effect of Neuromuscular Stimulation on Post-Transplan... | NCT01860820

Studies
The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

NCT01860820

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Oct 25, 2021Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Kidney Transplant
Kidney Pancreas Transplant
Edema

Interventions

Geko device

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Sep 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

May 21, 2013

First Submission Date that Met QC Criteria

May 22, 2013

First Posted Date

May 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2021

Last Update Posted Date

Oct 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Detailed Description

This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Best Medical Therapy	No Intervention	Participants will follow standard post-transplant protocols with IPC
Geko device	Active Comparator	Participants will be fitted with the device to ensure that it functions according to the manufacturer's instructions by a trained technician. This device will be changed every 24 hours. The device is worn on both legs and is worn for 24 hours a day. The device will first be put on the first day following the day of surgery and will then be changed the following day at the same time for a total of 7 days after surgery.	Device: Geko device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Geko device	Device		Geko device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease in edema	As measured by patient weight and leg diameter	Within 30 days post-transplant

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction	Patients will be asked to complete a questionnaire at these time points to assess their satisfaction	3 and 6 days after transplant

Other Outcomes

Measure	Description	Time Frame
Use of diuretics	Diuretic use wil be tracked for participants in each of the arms to assess wither there is a difference.	Within 30 days of transplant

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female
At least 18 years old
Undergoing kidney or kidney pancreas transplant surgery as the recipient
Able and willing to provide written informed consent
Absence of known peripheral vascular disease
Body Mass Index of between 18 and 34
Leg circumference at site of geko™ device placement is 24" or less

Exclusion Criteria:

History of deep vein thrombosis
Temporary or permanent cardiac pacing
Patient is pregnant
Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
Previous leg(s) amputation
Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
BMI index >36
Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
History of implantable brain or other stimulator
Patients who can not tolerate the stimulation from the GEKO device

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alp Sener, MD	Lawson Health Research Institute, London Health Sciences Centre	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre, University Hospital		London	Ontario	N6A 5A5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms