NCT04877847

Brief Summary

Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 24, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

April 27, 2021

Last Update Submit

April 10, 2023

Conditions

Contrast-induced NephropathyChronic Kidney Diseases

Keywords

coronary arteriographynitric oxide

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy Endpoint

    Incidence of acute kidney injury (AKI) defined as a greater than 0.3 mg/dl increase in serum creatinine (SCr)

    48 hours

  • Primary Safety Endpoint

    Composite of all Adverse Events (AE) including RENOBOOST (device) related adverse events, and major adverse events (MAE)

    30 days

Secondary Outcomes (11)

  • Incidence of Post Contrast Acute Kidney Injury

    at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)

  • Incidence of Post Contrast Acute Kidney Injury

    at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)

  • Incidence of contrast-induced nephropathy

    within 96 hours post-contrast exposure or need for RRT

  • Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)

    within 30 days after index procedure

  • Incidence of Post Contrast Acute Kidney Injury

    within 96 hours post-contrast exposure or need for RRT

  • +6 more secondary outcomes

Study Arms (2)

Low-Frequency Therapeutic Ultrasound

EXPERIMENTAL

LOTUS system will be operated per operated per normal instructions

Device: Low-frequency therapeutic ultrasound (LOTUS)

Sham Control

SHAM COMPARATOR

LOTUS system will be set to Control setting

Device: LOTUS System with Ultrasound Disabled

Interventions

Low-frequency therapeutic ultrasound (LOTUS)DEVICE

Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on per normal operating instructions.

Low-Frequency Therapeutic Ultrasound
LOTUS System with Ultrasound DisabledDEVICE

Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on and set to Control Setting.

Sham Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is greater than or equal to 18 years
  • Baseline renal dysfunction defined as one of the following:
  • eGFR greater than 30
  • eGFR 30-45, with or without risk factors for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
  • eGFR 45-60, with at least one risk factor for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
  • Participant is presenting for a planned percutaneous coronary intervention (PCI)
  • Participant scheduled to undergo cardiac catheterization including coronary arteriography that is anticipated to require at least 100 ml of iso-osmolar or low- osmolar contrast, and that is anticipated to include single-vessel stent implantation that does not include chronic total occlusion.
  • Participant had not been hospitalized or treated for a change in renal function within 30 days of enrollment.
  • Participant has provided written informed consent.
  • Participant is willing to comply with study follow-up requirements.

You may not qualify if:

  • Participant is anuric or currently undergoing renal replacement therapy.
  • Participant is currently taking oral nitrates.
  • Participant is undergoing a procedure requiring selective cannulation and injection of contrast into the renal arteries.
  • Participant presented with ST-segment elevation myocardial infarction.
  • Participant has a metal implant in the hip or lumbar spine.
  • Participant received or is anticipated to receive additional intravenous or intraarterial contrast from 7 days prior to cardiac catheterization to 4 days after cardiac catheterization.
  • Addition, discontinuation, or dose change of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, diuretic, trimethoprim, non-steroidal anti-inflammatory drugs, cimetidine, or metoclopramide with 7 days prior to cardiac catheterization.
  • Participant has a known allergy to contrast medium that cannot be adequately pre-medicated.
  • Participant has new-onset heart failure with New York Heart Association (NYHA) classification of III or IV within 30 days prior to the index procedure.
  • Recent stroke within 90 days prior to the index procedure.
  • Participant has known or suspected active infection at the time of the index procedure.
  • Participant is pregnant and/or breast-feeding or intends to become pregnant during the time of the study.
  • Participant is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
  • Participant is known to be incarcerated, mentally incompetent, and/or alcohol or drug abuser.
  • Participant is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or subject is planning to participate in such studies prior to the completion of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Henry Ford Hopsital

Detroit, Michigan, 48202, United States

Location

McLaren Northern Michigan

Petoskey, Michigan, 49770, United States

Location

University of Pennsylvania Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participant and clinical staff will be blinded to which arm the participant is randomized.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A total of up to 234 participants will be randomized 2:1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 7, 2021

Study Start

September 24, 2021

Primary Completion

January 23, 2023

Study Completion

January 23, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)