NCT02736799

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

Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers: A Sham Device Controlled, Single Center Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vibrant Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	Sham vibrating capsule	Sham device without vibration
DEVICE	Vibrant Capsule (1 vibration)	1 vibration/min
DEVICE	Vibrant Capsule (3 vibration)	3 vibration/min
DEVICE	Vibrant Capsule (5 vibration)	5 vibration/min

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-04-13
• Last updated: 2024-08-15
• Results posted: 2024-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study