Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT07151950
Brief Summary:
This mixed-methods usability study evaluates the effectiveness of the Obi Gen 3 robotic feeding device in meeting user needs among providers, caregivers, and patients. Participants will complete a one-week trial using Obi in home, school, or community settings, followed by feedback surveys and optional interviews. The study seeks to validate that the device design meets usability requirements prior to broader deployment.
Detailed Description:
The study assesses the usability of Obi Gen 3 through quantitative surveys and qualitative interviews across three user groups: providers, caregivers, and patients. Measures include the System Usability Scale (SUS), questions based on the Matching Person \& Technology (MPT) assessment and framework, and a custom Obi Medical Device Needs Assessment (MDNA). Data collection includes pre-trial in-office screening and post-trial surveys gathered remotely using Qualtrics. Optional follow-up interviews gather further feedback. The study aims to verify that the Obi Gen 3 meets its intended use and user needs in real-world environments.
Study:
NCT07151950
Study Brief:
Protocol Section:
NCT07151950