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The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)

NCT03228381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-04-03

No results posted yet for this study

Summary

The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.

Conditions

Interventions

DEVICE

BOSS Device

The BOSS will be comprised of a flexible, medical grade silicone handle and interchangeable inflatable medical grade silicone chambers. The inflatable chambers will vary in geometry and will have silicone tubing attached to them to allow inflation and deflation of the chamber while in the pericardial space. During open chest cardiac surgery, a small incision will be made in the pericardium to allow for insertion of the BOSS device into the pericardial space. Once inserted, the BOSS device will be positioned in different locations around the outside of the heart and anatomical and geometric changes will be observed echocardiographically. Use of the BOSS device is expected to lengthen the procedure by an average of 15 minutes, and in rare instances may be extended beyond 15 minutes as deemed appropriate by the investigator. The BOSS will be removed prior to continuing with the planned surgery.

Sponsors & Collaborators

  • Mardil Medical

    lead INDUSTRY

Principal Investigators

  • Sarah Hase · Mardil Medical

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2017-10-16
Completion
2017-10-16
FDA Device
Yes

Countries

  • United States
  • Paraguay

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228381 on ClinicalTrials.gov