Fuzzle System for Appetite Control and Weight Management (NCT07527559)
🩺 Plain-English Summary (8th-Grade Level)
This study is evaluating whether the Fuzzle intraoral device can help adults with obesity lose weight when used alongside standard lifestyle counseling. Participants in this study will receive guidance on diet and behavior to support weight loss. Some participants will also receive the Fuzzle device, a custom-made removable oral appliance worn during the day. The study will compare weight loss outcomes between participants who use the Fuzzle device and those who follow lifestyle counseling alone over a 16-week period. Researchers will also explore whether use of the device increases the number of participants who achieve meaningful weight loss and may evaluate changes in selected metabolic markers in a subset of participants.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (9 items).
Location: DM Clinical Research — Bradenton, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participation in another weight-loss clinical study within 90 days
- Pregnancy, breastfeeding, or intent to become pregnant during the study period
- History of eating disorders or uncontrolled psychiatric illness
- Oral or dental conditions preventing safe device use
- Current use of prescription or over-the-counter weight-loss medications
- A1C \>8.0% at screening (glycemic subset exclusion only)
- Unstable diabetes medication regimen (glycemic subset exclusion only)
- Any medical condition that, in the investigator's judgment, would interfere with safe participation
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- DM Clinical Research — Bradenton, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.