Trial Outcomes & Findings for Safety and Efficacy of the SMART Device for Overweight and Obese Adults (NCT NCT02119299)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

16 weeks

Results posted on

2017-07-17

Participant Flow

Per protocol, there were two screening visits prior to the run-in visit to assess subject eligibility and oral health. A total of 4 visits (2 screening visits, 1 run-in visit and 1 wash-out visit) were included prior to the baseline visit.

Participant milestones

Participant milestones
Measure	SMART Device Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Overall Study STARTED	76
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	SMART Device Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Overall Study Withdrawal by Subject	7
Overall Study Lack of Efficacy	1
Overall Study Pregnancy	1

Baseline Characteristics

Safety and Efficacy of the SMART Device for Overweight and Obese Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SMART Device n=76 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.8 years STANDARD_DEVIATION 7.92 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0	12 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Per Protocol population

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0	2.93 % TBL Standard Deviation 3.531

SECONDARY outcome

Timeframe: 16 weeks

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Mean Percentage Excess Weight Loss (EWL)	18.76 percentage of excess weight loss Standard Deviation 24.51

SECONDARY outcome

Timeframe: 16 weeks

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Mean Absolute Weight Loss (kg)	2.35 Body weight (kg) Standard Deviation 2.99

SECONDARY outcome

Timeframe: 16 weeks

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Proportion of Subjects Achieving ≥4% Weight Loss	16 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Proportion of Subjects Achieving ≥12% EWL	24 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Per Protocol Population

The measured relationship between SMART device usage and total weight loss.

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Percentage Total Body Loss and Treatment Compliance Correlation	.025 Pearson correlation

SECONDARY outcome

Timeframe: Week 16

Device compliance is calculated as 100\*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).

Outcome measures

Outcome measures
Measure	SMART Device n=40 Participants Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Device Compliance	69 % of eating episodes with device use Standard Deviation 14.13

Adverse Events

SMART Device

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SMART Device n=76 participants at risk Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Pregnancy, puerperium and perinatal conditions Pregnancy	1.3% 1/76 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Richard P. Schneider

Scientific Intake

Phone: 917-676-6251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60