Trial Outcomes & Findings for Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers (NCT NCT02736799)

Results Overview

The main outcome measure is the Gastro-duodenal manometry measurement of the first hour postprandial distal antral motility index (MI), which is calculated as: MI = loge (sum of amplitude x number of contractions + 1) every 15 minutes following postcibal period (60 min). Effect size is the difference between means as a percentage of the mean index between the treatment groups. Estimated effect sizes are based on a paired t-test with the expected difference in mean of 1.6 motility index units in distal antral activity or 13.6% change in the antral motility index in ACTIVE compared to SHAM. It is to be noted that this is on a logarithmic scale and, therefore, a 10% change constitutes a clinically relevant difference. A higher MI value represents a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

1 hour

Results posted on

2024-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Vibrating Capsule Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min
Overall Study STARTED	6	6	6	6
Overall Study COMPLETED	6	6	6	5
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham Vibrating Capsule Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min
Overall Study stopped study after receipt of Capsule #1 due to sore throat.	0	0	0	1

Baseline Characteristics

Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Vibrating Capsule n=6 Participants Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) n=6 Participants 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) n=6 Participants 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) n=6 Participants 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min	Total n=24 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 15.80 • n=5 Participants	38.17 years STANDARD_DEVIATION 18.05 • n=7 Participants	28.5 years STANDARD_DEVIATION 10.82 • n=5 Participants	28.17 years STANDARD_DEVIATION 10.26 • n=4 Participants	32 years STANDARD_DEVIATION 13.89 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Body mass index (BMI)	26.75 kg/m^2 STANDARD_DEVIATION 3.02 • n=5 Participants	26.3 kg/m^2 STANDARD_DEVIATION 4.97 • n=7 Participants	26.83 kg/m^2 STANDARD_DEVIATION 1.89 • n=5 Participants	26.73 kg/m^2 STANDARD_DEVIATION 4.745 • n=4 Participants	26.57 kg/m^2 STANDARD_DEVIATION 3.66 • n=21 Participants

PRIMARY outcome

Timeframe: 1 hour

The main outcome measure is the Gastro-duodenal manometry measurement of the first hour postprandial distal antral motility index (MI), which is calculated as: MI = loge (sum of amplitude x number of contractions + 1) every 15 minutes following postcibal period (60 min). Effect size is the difference between means as a percentage of the mean index between the treatment groups. Estimated effect sizes are based on a paired t-test with the expected difference in mean of 1.6 motility index units in distal antral activity or 13.6% change in the antral motility index in ACTIVE compared to SHAM. It is to be noted that this is on a logarithmic scale and, therefore, a 10% change constitutes a clinically relevant difference. A higher MI value represents a better outcome.

Outcome measures

Outcome measures
Measure	Sham Vibrating Capsule n=6 Participants Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) n=6 Participants 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) n=6 Participants 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) n=6 Participants 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min
Gastroduodenal Manometry Measurement	9.862 motility index units (see Description) Standard Deviation 1.549	10.38 motility index units (see Description) Standard Deviation 0.864	10.38 motility index units (see Description) Standard Deviation 1.469	8.433 motility index units (see Description) Standard Deviation 3.38

PRIMARY outcome

Timeframe: 4 hours

The median solid gastric emptying half-time in minutes from the stomach after a mixed meal as measured by scintigraphy. Approximately thirty minutes following ingestion of the Vibarnt / sham capsule, subjects ingested a standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior gamma camera images were obtained immediately following ingestion of the meal and every 15 minutes until 240 minutes.

Outcome measures

Outcome measures
Measure	Sham Vibrating Capsule n=6 Participants Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) n=6 Participants 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) n=6 Participants 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) n=5 Participants 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min
Gastric Emptying of Solids - T1/2	120.7 Minutes Standard Deviation 31.78	132.3 Minutes Standard Deviation 34.38	134.7 Minutes Standard Deviation 35.89	132.2 Minutes Standard Deviation 43.91

SECONDARY outcome

Timeframe: 1 hour

Gastric emptying scintigraphy (GES) is the 'gold standard' measurement for assessing stomach emptying rate. Stomach emptying was measured following ingestion of a standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior gamma camera images were obtained immediately following ingestion of the meal and every 15 minutes until 240 minutes. The outcome of GES at one hour is measuring the rate of solid emptying from the stomach after one hour in each of the study arms. A higher Fraction of solids emptying represents faster stomach emptying.

Outcome measures

Outcome measures
Measure	Sham Vibrating Capsule n=6 Participants Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) n=6 Participants 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) n=6 Participants 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) n=5 Participants 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min
Gastric Emptying at One Hour	0.298 Fraction of solids emptying Standard Deviation 0.0979	0.273 Fraction of solids emptying Standard Deviation 0.0885	0.248 Fraction of solids emptying Standard Deviation 0.0679	0.264 Fraction of solids emptying Standard Deviation 0.0532

SECONDARY outcome

Timeframe: 2 hours

Gastric emptying scintigraphy (GES) is the 'gold standard' measurement for assessing stomach emptying rate. Stomach emptying was measured following ingestion of a standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior gamma camera images were obtained immediately following ingestion of the meal and every 15 minutes until 240 minutes. The outcome of GES at two hours is measuring the rate of solid emptying from the stomach after two hours in each of the study arms. A higher Fraction of solids emptying represents faster stomach emptying.

Outcome measures

Outcome measures
Measure	Sham Vibrating Capsule n=6 Participants Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) n=6 Participants 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) n=6 Participants 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) n=4 Participants 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min
Gastric Emptying at Two Hours	0.495 Fraction of solids emptying Standard Deviation 0.125	0.485 Fraction of solids emptying Standard Deviation 0.168	0.457 Fraction of solids emptying Standard Deviation 0.104	0.498 Fraction of solids emptying Standard Deviation 0.177

SECONDARY outcome

Timeframe: 30 minutes

First 0.5h postprandial distal antral motility index (Gastroduodenal Motility index (MI) MI formula: MI = loge (sum of amplitude x number of contractions + 1). Effect size is the difference between means as a percentage of the mean index between the treatment groups. Estimated effect sizes are based on a paired t-test with expected difference in mean of 1.6 motility index units in distal antral activity or 13.6% change in the antral motility index in ACTIVE compared to SHAM. It is to be noted that this is on a logarithmic scale and, therefore, an 10% change constitutes a clinically relevant difference. A higher MI value represents a better outcome.

Outcome measures

Outcome measures
Measure	Sham Vibrating Capsule n=6 Participants Sham vibrating capsule Sham vibrating capsule: Sham device without vibration	Vibrant Capsule (1 Vibration) n=6 Participants 1 vibration/min Vibrant Capsule (1 vibration): 1 vibration/min	Vibrant Capsule (3 Vibration) n=6 Participants 3 vibrations/min Vibrant Capsule (3 vibration): 3 vibration/min	Vibrant Capsule (5 Vibration) n=6 Participants 5 vibrations/min Vibrant Capsule (5 vibration): 5 vibration/min
Postprandial Distal Antral Motility Index	10.3 motility index units (See Description) Standard Deviation 1.102	10.38 motility index units (See Description) Standard Deviation 1.446	10.55 motility index units (See Description) Standard Deviation 1.532	10.34 motility index units (See Description) Standard Deviation 1.141

Adverse Events

Sham Vibrating Capsule

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibrant Capsule (1 Vibration)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibrant Capsule (3 Vibration)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibrant Capsule (5 Vibration)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tal Malina / Clinical trials manager

Vibrant LTD

Phone: +972 046663322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Permission to use study data is required
Publication restrictions are in place

Restriction type: OTHER