Could a pill replace the scope? new capsule aims to spot stomach bleeding in minutes
NCT ID NCT06951490
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a small, swallowable capsule called PillSense that can detect blood in the upper digestive tract within about 10 minutes. Researchers want to see if a negative result from the capsule can safely predict that a hospitalized patient with anemia or a positive stool test does not need an urgent endoscopy. The study involves 20 adults and will compare the capsule's findings with standard care to see if it could one day help avoid invasive procedures and speed up safe discharge.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PillSense™ capsule (ingestible device that detects blood in the upper digestive tract)
- What this could lead to
- If successful, this could provide a quick, non-invasive way to decide if patients with anemia or positive stool tests can be safely discharged without an endoscopy.
- What could go wrong
- This is a very small early study with only 20 participants, and the capsule test results won't change current care. It may not be accurate enough to replace standard procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of hospitalized adult patients who have been referred to the gastroenterology service for evaluation of unexplained anemia and/or a positive fecal occult blood test (hemoccult) in the absence of overt gastrointestinal bleeding. These patients represent a group commonly subjected to diagnostic endoscopy despite the often-low diagnostic yield of such procedures.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older * Able to provide informed consent * Hospitalized patients who have been referred to the gastroenterology service for: A positive hemoccult (fecal occult blood test) and/or Anemia, In the absence of overt gastrointestinal bleeding - Overt gastrointestinal bleeding is defined as the presence of: Melena (black, tarry stools) Hematochezia (bright red blood per rectum) Hematemesis (vomiting blood) Exclusion Criteria: * Hemodynamic instability, defined as: Systolic blood pressure \< 90 mm Hg Pulse \> 120 bpm * Presence of overt gastrointestinal bleeding (melena, hematochezia, or hematemesis) * Conditions that might contraindicate use of an ingestible capsule, such as: Dysphagia or odynophagia Swallowing disorder Altered mental status Zenker's diverticulum Crohn's disease Previous GI surgery Suspected ileus or bowel obstruction GI perforation GI motility disorders (e.g., esophageal dysmotility, gastroparesis) \- Known upper GI pathology, such as: Esophageal or gastric cancer Recent upper GI ulcer bleeding (within 3 months) Recent upper GI procedures or surgeries * Presence of a cardiac implantable electronic device (CIED) * Pregnant or lactating women * Planned MRI before capsule excretion
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
AdventHealth Orlando
Orlando, Florida, 32804, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can IV iron boost blood levels and daily energy for mothers before and after delivery?
- Iron boost before heart surgery may cut need for donor blood
- Can scheduled malaria drugs shield infants from severe illness?
- Can a simple preventive drug cut malaria and anemia in infants?
- Can catching anemia months before joint surgery speed recovery?
- Can a simple blood test predict surgery risks?