An interventional study of Sham vibrating capsule and Vibrant Capsule (1 vibration) in Gastroparesis, sponsored by Vibrant Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Vibrant Ltd. · Not applicable, Interventional, and Other
The Vibrant capsule is a novel vibrating device for the treatment of gastrointestinal disorders. The effect of different vibrations on the motor functions of the gastrointestinal tract are unclear. The study will focus on the stomach in healthy volunteers.
The study will compare the effects of Vibrant capsule treatment and Sham capsule treatment on gastric emptying and gastric motility in healthy volunteers.
Healthy volunteers participants were randomized to one of 4 treatment groups: sham VIBRANT or vibrating VIBRANT capsule at rates of 1, 3 or 5 per minute. The studies were conducted in one day.
Following an overnight fast, participants underwent introduction of the multilumen manometric catheter into the proximal small intestine with sensors across the antroduodenal junction. A 4-meter Teflon® (green) guidewire and manometry tube were placed transnasally and advanced into the duodenum with the distal end of the manometry tube within the distal duodenum or proximal jejunum.
Following placement of the manometry tube a 30 minute baseline motility assessment was performed followed by the first of two VIBRANT OR SHAM VIBRANT CAPSULES administered as randomly assigned. Motility assessment performed for an additional 25-30 minutes before the digestion of the standardized breakfast test meal. A single spot image will be obtained to document the location of the capsule prior to the meal.
Approximately thirty minutes following ingestion of the capsule, participants ingested a standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior gamma camera images obtained immediately following ingestion of the meal and every 15 minutes until 240 minutes. In addition, every 30 minutes one hundred millimeter Visual analog scales (VAS) recorded to assess levels of nausea, fullness, gas, and abdominal pain.
Participants were seated in a semi-recumbent position (\~45 degrees) for recording motility and obtaining anterior scintigraphy images simultaneously. Following the 90-minute scan, the participants ingested a second active VIBRANT or sham capsule. Subsequent scans continued at scheduled intervals until 240 minutes after the test meal ingestion to complete the assessment of gastric emptying.
306 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's enrollment of 24 is below the median of 44 across 201 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Vibrant Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Exclusion Criteria:
Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:
Sham vibrating capsule
Device: Sham vibrating capsule
1 vibration/min
Device: Vibrant Capsule (1 vibration)
3 vibrations/min
Device: Vibrant Capsule (3 vibration)
5 vibrations/min
Device: Vibrant Capsule (5 vibration)
Sham device without vibration
1 vibration/min
3 vibration/min
5 vibration/min
Gastroduodenal Manometry Measurement
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.
Time frame: 1 hour
Gastric Emptying of Solids - T1/2
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.
Time frame: 4 hours
Gastric Emptying at One 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.
Time frame: 1 hour
Gastric Emptying at Two 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.
Time frame: 2 hours
Postprandial Distal Antral Motility Index
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.
Time frame: 30 minutes
| Milestone | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 |
| Completed | 6 | 6 | 6 | 5 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Stopped study after receipt of capsule #1 due to sore throat. | 0 | 0 | 0 | 1 |
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.
| motility index units (see Description) | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) |
|---|---|---|---|---|
| Gastroduodenal Manometry Measurement | 9.862 ± 1.549 | 10.38 ± 0.864 | 10.38 ± 1.469 | 8.433 ± 3.38 |
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.
| Minutes | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) |
|---|---|---|---|---|
| Gastric Emptying of Solids - T1/2 | 120.7 ± 31.78 | 132.3 ± 34.38 | 134.7 ± 35.89 | 132.2 ± 43.91 |
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.
| Fraction of solids emptying | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) |
|---|---|---|---|---|
| Gastric Emptying at One Hour | 0.298 ± 0.0979 | 0.273 ± 0.0885 | 0.248 ± 0.0679 | 0.264 ± 0.0532 |
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.
| Fraction of solids emptying | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) |
|---|---|---|---|---|
| Gastric Emptying at Two Hours | 0.495 ± 0.125 | 0.485 ± 0.168 | 0.457 ± 0.104 | 0.498 ± 0.177 |
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.
| motility index units (See Description) | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) |
|---|---|---|---|---|
| Postprandial Distal Antral Motility Index | 10.3 ± 1.102 | 10.38 ± 1.446 | 10.55 ± 1.532 | 10.34 ± 1.141 |
Collected over 6 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham Vibrating Capsule | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Vibrant Capsule (1 Vibration) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Vibrant Capsule (3 Vibration) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Vibrant Capsule (5 Vibration) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) | Total |
|---|---|---|---|---|---|
| Mean | 37 ± 15.80 | 38.17 ± 18.05 | 28.5 ± 10.82 | 28.17 ± 10.26 | 32 ± 13.89 |
| Sex: Female, Male(Participants) | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) | Total |
|---|---|---|---|---|---|
| Female | 3 | 4 | 4 | 4 | 15 |
| Male | 3 | 2 | 2 | 2 | 9 |
| Body mass index (BMI)(kg/m^2) | Sham Vibrating Capsule | Vibrant Capsule (1 Vibration) | Vibrant Capsule (3 Vibration) | Vibrant Capsule (5 Vibration) | Total |
|---|---|---|---|---|---|
| Mean | 26.75 ± 3.02 | 26.3 ± 4.97 | 26.83 ± 1.89 | 26.73 ± 4.745 | 26.57 ± 3.66 |
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