Trial Outcomes & Findings for Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients (NCT NCT04017910)

NCT ID: NCT04017910

Last Updated: 2022-10-12

Results Overview

Data collection to verify accuracy

• Recruitment status: TERMINATED
• Target enrollment: 17 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2022-10-12

Participant Flow

Participant milestones

Measure	EchoMark/EchoSure Stage 1 EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

Baseline characteristics by cohort

Measure	EchoMark/EchoSure Stage 1 n=17 Participants EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Data was not collected.

Data collection to verify accuracy

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 Weeks

Population: Data was not collected.

Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 Weeks

Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period.

Outcome measures

Measure	EchoMark/EchoSure Stage 1 n=17 Participants EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
Safety Endpoint	16 Participants

Adverse Events

EchoMark/EchoSure Stage 1

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Measure	EchoMark/EchoSure Stage 1 n=17 participants at risk EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
Infections and infestations Seroma / Possible Infection	5.9% 1/17 • Number of events 1 • 1 year

Other adverse events

Measure	EchoMark/EchoSure Stage 1 n=17 participants at risk EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process.
Surgical and medical procedures Edema	17.6% 3/17 • Number of events 3 • 1 year
Surgical and medical procedures Seroma	17.6% 3/17 • Number of events 3 • 1 year

Additional Information

Katy Feeny

Sonavex

Phone: 443-862-2024

Email: kfeeny@sonavex.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place