Trial Outcomes & Findings for Spatz Adjustable Balloon for Obesity (SABO) (NCT NCT02812160)

NCT ID: NCT02812160

Last Updated: 2021-05-28

Results Overview

The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 288 participants
• Primary outcome timeframe: 32 weeks
• Results posted on: 2021-05-28

Participant Flow

Participant milestones

Measure	Spatz3 Adjustable Balloon Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Control Dietary and Exercise counselling
Overall Study STARTED	187	101
Overall Study COMPLETED	187	101
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spatz Adjustable Balloon for Obesity (SABO)

Baseline characteristics by cohort

Measure	Spatz3 Adjustable Balloon n=187 Participants Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Control n=101 Participants Dietary and Exercise counselling	Total n=288 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	187 Participants n=5 Participants	101 Participants n=7 Participants	288 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44.4 years STANDARD_DEVIATION 8.9 • n=5 Participants	44.0 years STANDARD_DEVIATION 8.9 • n=7 Participants	44.3 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	90 Participants n=7 Participants	252 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	11 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	26 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) White	132 Participants n=5 Participants	72 Participants n=7 Participants	204 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	187 Participants n=5 Participants	101 Participants n=7 Participants	288 Participants n=5 Participants
BMI	35.8 Kg/m^2 STANDARD_DEVIATION 2.6 • n=5 Participants	35.8 Kg/m^2 STANDARD_DEVIATION 2.7 • n=7 Participants	35.8 Kg/m^2 STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

Timeframe: 32 weeks

The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.

Outcome measures

Measure	Spatz3 Adjustable Balloon n=187 Participants Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Control n=101 Participants Dietary and Exercise counselling
Percent Change in Total Body Weight (%TBL) .	15.0 TBL% Standard Deviation 7.2	3.3 TBL% Standard Deviation 5.6

Adverse Events

Spatz3 Adjustable Balloon

Serious events: 10 serious events

Other events: 184 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spatz3 Adjustable Balloon n=187 participants at risk Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Control n=101 participants at risk Dietary and Exercise counselling
Gastrointestinal disorders Gastrointestinal disorders	3.7% 7/187 • Number of events 24 • 32 weeks	0.99% 1/101 • Number of events 1 • 32 weeks
Metabolism and nutrition disorders Metabolism and nutrition disorders	2.1% 4/187 • Number of events 5 • 32 weeks	0.00% 0/101 • 32 weeks

Other adverse events

Measure	Spatz3 Adjustable Balloon n=187 participants at risk Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Control n=101 participants at risk Dietary and Exercise counselling
Gastrointestinal disorders Gastrointestinal disorders	98.4% 184/187 • Number of events 2522 • 32 weeks	31.7% 32/101 • Number of events 84 • 32 weeks

Additional Information

Jeffrey Brooks MD

Spatz FGIA Inc.

Phone: 1-516-303-0613

Email: jeff@spatzmedical.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place