Detection of Blood in the GI Lumen With HemoPill Acute
ConditionUpper GI Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorStony Brook University
About this trial
The goal of this clinical trial is to learn if the HemoPill acute (trial device) can detect the presence of blood in participants suspected of having upper gastrointestinal bleeding. The main question it aims to answer is:
-What is the clinical relationship between the HemoPill acute (trial device) and endoscopy (control procedure) in detecting the presence of blood/bleeding in the upper gastrointestinal tract?
Participants will:
* Swallow the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure. * Keep the device receiver close to their body from the time of swallowing until completion of their endoscopy procedure. * Return for a follow-up visit(s) to check for the presence or absence of the HemoPill acute device and to report the occurrence of any adverse or serious adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Greater than or equal to 22 years of age.
Scheduled for upper endoscopy due to suspicion of upper GI bleed as part of standard of clinical care.
Literate and able to provide written informed consent.
Disqualifiers
Less than 22 years of age.
Not undergoing upper endoscopy due to suspicion of upper GI bleed as part of standard of clinical care.
Known GI obstruction, stricture, or fistula;
Dysphagia, Zenker's diverticulum, or other swallowing disorders;
Trial design
Design model
Single group
Treatments tested in this trial
HemoPill acute
DeviceParticipants will ingest the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: HemoPill acuteExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity
To determine the clinical relationship (sensitivity \& specificity) of blood detection in the upper GI lumen between the HemoPill acute (trial) and endoscopic examination (control).
Time frame
From enrollment to the end of the endoscopic examination.Secondary outcomes
1
Clinical effectiveness - Predictive Values
To demonstrate the Negative and Positive Predictive Values by indicating the presence/absence of blood in the upper GI tract.
Time frame
From enrollment to the end of the endoscopic examination.2
Transit and excretion
Determination of capsule presence/absence via X-ray radiography \& HemoPill acute receiver connectivity.
Time frame
At Follow-up Visit 1 7-14 days post-ingestion and Follow-up Visit 2 15-21 days post-ingestion (if needed).3
Technical effectiveness
To determine rate of successful data transmission of the HemoPill acute to the HemoPill receiver.
Time frame
From enrollment to the end of the endoscopic examination.4
Safety profile and complications
To determine the safety profile or rate of adverse events/serious adverse events/complications of the HemoPill acute.
Time frame
From enrollment to Follow-up Visit 1 7-14 days post-ingestion or Follow-up Visit 2 15-21 days post-ingestion (if needed).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stony Brook University
Lead sponsor
Ovesco Endoscopy AG
Collaborator
Source ClinicalTrials.gov