Home With TablO outcoMEs (HOME) Registry

Home With TablO outcoMEs (HOME) Registry

Sponsors

Lead Sponsor: Outset Medical

Source Outset Medical
Brief Summary

Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.

Overall Status Recruiting
Start Date July 14, 2020
Completion Date January 31, 2023
Primary Completion Date January 31, 2023
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Weekly Standardized Dialysis Adequacy 12-months
Enrollment 250
Condition
Intervention

Intervention Type: Device

Intervention Name: Tablo Hemodialysis System

Description: Home hemodialysis treatments ~4 times a week.

Arm Group Label: Tablo Hemodialysis System

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Participant weighs ≥ 34kg.

- Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.

- Participant has identified an observer to be trained and available, who is not a paid dialysis professional. The identified observer must be considered competent in the use of the device by the prescribing physician.

Exclusion Criteria:

- Participant and/or observer is unable to read English or Spanish.

- Participant has a home environment that is deemed inappropriate for home dialysis.

- Participant has prior experience using Tablo in the home setting.

- Participant is pregnant or plans to become pregnant.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Josh Schumacher

Phone: (669) 231-8200

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Berkshire Medical Center Tammy Bator, RN David Henner, M.D. Principal Investigator
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Tablo Hemodialysis System

Description: Home dialysis treatment with the Tablo Hemodialysis System

Acronym HOME
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov