Trial Outcomes & Findings for Feasibility of Placing Bravo PH Capsule in Proximal Esophagus (NCT NCT00378898)

NCT ID: NCT00378898

Last Updated: 2017-04-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2017-04-04

Participant Flow

Subjects were 18 years of age or older and scheduled for esophagogastroduodenoscopy (EGD) and wireless pH testing for physiologic assessment of esophageal acid exposure for typical gastroesophageal reflux disease (GERD) symptoms such as heartburn and regurgitation or for extra-esophageal reflux symptoms such as cough or asthma at Vanderbilt.

Participant milestones

Measure	EGD With Sham BRAVO Capsule Placement Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.	EGD With BRAVO Capsule Bravo PH capsule:egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo
Overall Study STARTED	17	22
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Measure	EGD With Sham BRAVO Capsule Placement Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.	EGD With BRAVO Capsule Bravo PH capsule:egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo
Overall Study Withdrawal by Subject	5	10
Overall Study Protocol Violation	1	1

Baseline Characteristics

Feasibility of Placing Bravo PH Capsule in Proximal Esophagus

Baseline characteristics by cohort

Measure	EGD With BRAVO Capsule n=11 Participants Bravo PH capsule: egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo	EGD With Sham BRAVO Capsule Placement n=11 Participants Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.	Total n=22 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	50 years n=7 Participants	51 years n=5 Participants
Sex/Gender, Customized Female	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Sex/Gender, Customized Male	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Measure	EGD With BRAVO Capsule n=11 Participants Bravo PH capsule: egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo	Sham Comparator: EGD With Sham BRAVO Capsule Placement n=11 Participants Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort	2 participants	0 participants

SECONDARY outcome

Timeframe: 48 hours

Population: 2 subjects had to have the BRAVO removed before 48 hours due to reported discomfort in the BRAVO placement group so chest pain scores were obtained for 9 of the 11 subjects.

Edmonton Symptom Assessment is used to measure the presence and change in symptoms.

Outcome measures

Measure	EGD With BRAVO Capsule n=9 Participants Bravo PH capsule: egd with bravo placement Fluoroscopy: one time "xray" to determine evacuation of bravo	Sham Comparator: EGD With Sham BRAVO Capsule Placement n=11 Participants Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
Subjects Reporting Chest Pain	6 Participants	3 Participants

Adverse Events

EGD With BRAVO Capsule

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

EGS With Sham BRAVO Capsule Placement

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EGD With BRAVO Capsule n=11 participants at risk Bravo PH capsule: egd with bravo placement. Analysis is for participants who completed the study. Fluoroscopy: one time "xray" to determine evacuation of bravo	EGS With Sham BRAVO Capsule Placement n=11 participants at risk Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. Analysis is for participants who completed the study.
Surgical and medical procedures Chest pain	63.6% 7/11 • Patients underwent baseline EGD and 48-hour wireless pH monitoring. Assessment of symptoms and any adverse events were completed 48 hours after the study intervention.	27.3% 3/11 • Patients underwent baseline EGD and 48-hour wireless pH monitoring. Assessment of symptoms and any adverse events were completed 48 hours after the study intervention.

Additional Information

Dr. Michael Vaezi

Vanderbilt University Medical Center

Phone: 615-322-3739

Email: michael.vaezi@vanderbilt.edu

Results disclosure agreements

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