Occult Gastrointestinal BleedingPillSense™NCT06951490
PillSense Use in Anemia and Hemoccult
An observational study of Occult Gastrointestinal Bleeding and Upper Gastrointestinal Bleeding (UGIB), run by AdventHealth at 1 site in United States.
Trial summary
In this study, participants will be offered a PillSense™ capsule, a small capsule to swallow, which can detect the presence of blood in the upper digestive tract within about 10 minutes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occult Gastrointestinal Bleeding, Upper Gastrointestinal Bleeding (UGIB)
- What is being tested?
- PillSense™
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Presence of a cardiac implantable electronic device (CIED)
- Pregnant or lactating women
- Planned MRI before capsule excretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing Negative PillSense™ for Safe Discharge in Patients With Positive Hemoccult and/or Unexplained Anemia
In this study, participants will be offered a PillSense™ capsule, a small capsule to swallow, which can detect the presence of blood in the upper digestive tract within about 10 minutes. The results of this capsule test will not alter the current care plan but will help us assess whether PillSense™ can be used in the future as a standalone test to determine if it is safe for patients to be discharged with anemia or a positive stool test without other signs of gastrointestinal bleeding. This study aims to collect data that will help determine if the PillSense™ capsule could one day reduce the need for more invasive procedures while hospitalized, like endoscopy, and ensure safe patient discharge.
- Being tested
- PillSense™
- Keywords
- PillSense, Upper Gastrointestinal Bleeding, GI Bleed Detection, Positive Hemoccult, Capsule Endoscopy, Non-invasive Diagnostics, Real-time GI Bleed Detection
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillSense™Device
The PillSense™ System is a prescription only device consisting of a reusable receiver and single-use ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients Undergoing PillSense™ Testing | This group includes hospitalized adult patients who have been referred to gastroenterology services for unexplained anemia and/or a positive fecal occult blood test (hemoccult) in the absence of overt gastrointestinal bleeding (e.g., no melena, hematemesis, or hematochezia). All participants will ingest the PillSense™ capsule. Receives: Device: PillSense™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Negative PillSense™ Result in Predicting Safe Discharge
To measure the percentage of participants with a negative Pillsense™ result who are safely discharged from the hospital without requiring urgent endoscopic intervention or experiencing adverse events during their hospitalization.
Measured: 24 hours
Secondary outcomes (5)
False Negative Rate of PillSense™
Rate at which a negative PillSense™ results fail to detect clinically significant upper gastrointestinal bleeding later confirmed by endoscopy.
Measured: During hospitalization (up to 72 hours after capsule ingestion)
Timing of Endoscopic Intervention
The average number of hours between taking the PillSense capsule and having an upper endoscopy, compared between patients with positive and negative PillSense results, to see if test results affect how quickly endoscopy is done.
Measured: 24-72 hours
Length of Hospital Stay
Measure the average hospital length of stay (in days) between patients with positive and negative PillSense™ results to evaluate whether test outcome is associated with differences in duration of hospitalization.
Measured: 24-72 hours
30-Day Readmission Rate
Rate of readmission within 30 days post-discharge between patients with positive and negative PillSense™ results.
Measured: 30 days post-discharge
30-Day Mortality
All-cause mortality rate between patients with positive and negative PillSense™ results.
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start15 May 2025
- Primary completion14 May 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Occult Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- EnteraSense Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951490
- Sponsor's protocol ID
- 2232176
- Acronym
- PillSense™
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not be sharing information from this study.
Publications
Yung DE, Plevris JN, Koulaouzidis A. Short article: Aspiration of capsule endoscopes: a comprehensive review of the existing literature. Eur J Gastroenterol Hepatol. 2017 Apr;29(4):428-434. doi: 10.1097/MEG.0000000000000821.
PubMed 28253209Nemeth A, Wurm Johansson G, Nielsen J, Thorlacius H, Toth E. Capsule retention related to small bowel capsule endoscopy: a large European single-center 10-year clinical experience. United European Gastroenterol J. 2017 Aug;5(5):677-686. doi: 10.1177/2050640616675219. Epub 2016 Oct 16.
PubMed 28815031Rondonotti E, Soncini M, Girelli C, Ballardini G, Bianchi G, Brunati S, Centenara L, Cesari P, Cortelezzi C, Curioni S, Gozzini C, Gullotta R, Lazzaroni M, Maino M, Mandelli G, Mantovani N, Morandi E, Pansoni C, Piubello W, Putignano R, Schalling R, Tatarella M, Villa F, Vitagliano P, Russo A, Conte D, Masci E, de Franchis R; AIGO, SIED and SIGE Lombardia. Small bowel capsule endoscopy in clinical practice: a multicenter 7-year survey. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1380-6. doi: 10.1097/MEG.0b013e3283352ced.
PubMed 20173646Lim YJ, Lee OY, Jeen YT, Lim CY, Cheung DY, Cheon JH, Ye BD, Song HJ, Kim JS, Do JH, Lee KJ, Shim KN, Chang DK, Park CH, Jang BI, Moon JS, Chun HJ, Choi MG, Kim JO; Korean Gut Image Study Group. Indications for Detection, Completion, and Retention Rates of Small Bowel Capsule Endoscopy Based on the 10-Year Data from the Korean Capsule Endoscopy Registry. Clin Endosc. 2015 Sep;48(5):399-404. doi: 10.5946/ce.2015.48.5.399. Epub 2015 Sep 30.
PubMed 26473123Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
PubMed 20152309Fernandez-Urien I, Carretero C, Gonzalez B, Pons V, Caunedo A, Valle J, Redondo-Cerezo E, Lopez-Higueras A, Valdes M, Menchen P, Fernandez P, Munoz-Navas M, Jimenez J, Herrerias JM. Incidence, clinical outcomes, and therapeutic approaches of capsule endoscopy-related adverse events in a large study population. Rev Esp Enferm Dig. 2015 Dec;107(12):745-52. doi: 10.17235/reed.2015.3820/2015.
PubMed 26671587Rezapour M, Amadi C, Gerson LB. Retention associated with video capsule endoscopy: systematic review and meta-analysis. Gastrointest Endosc. 2017 Jun;85(6):1157-1168.e2. doi: 10.1016/j.gie.2016.12.024. Epub 2017 Jan 6.
PubMed 28069475Sachdev MS, Leighton JA, Fleischer DE, Heigh RI, Hara AK, Post JA, Erickson PJ, Sharma VK. A prospective study of the utility of abdominal radiographs after capsule endoscopy for the diagnosis of capsule retention. Gastrointest Endosc. 2007 Nov;66(5):894-900. doi: 10.1016/j.gie.2007.06.066.
PubMed 17963875Akiki K, Mahmoud T, Alqaisieh MH, Sayegh LN, Lescalleet KE, Abu Dayyeh BK, Wong Kee Song LM, Larson MV, Bruining DH, Coelho-Prabhu N, Buttar NS, Sedlack RE, Chandrasekhara V, Leggett CL, Law RJ, Rajan E, Gleeson FC, Alexander JA, Storm AC. A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial. Gastrointest Endosc. 2024 May;99(5):712-720. doi: 10.1016/j.gie.2023.11.051. Epub 2023 Dec 6.
PubMed 38065512Niv E, Elis A, Zissin R, Naftali T, Novis B, Lishner M. Iron deficiency anemia in patients without gastrointestinal symptoms--a prospective study. Fam Pract. 2005 Feb;22(1):58-61. doi: 10.1093/fampra/cmh705. Epub 2005 Jan 11.
PubMed 15644385Stray N, Weberg R. A prospective study of same day bi-directional endoscopy in the evaluation of patients with occult gastrointestinal bleeding. Scand J Gastroenterol. 2006 Jul;41(7):844-50. doi: 10.1080/00365520500495789.
PubMed 16785199Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
PubMed 18725159Lin K, Linn S, Ramai D, et al. Clinical Features and Outcomes in Hospitalized Patients With Positive FOBT Undergoing Bidirectional Endoscopy - A Single-Center Experience: 2736. American Journal of Gastroenterology. 2018;113(Supplement):S1523. doi:10.14309/00000434-201810001-02735
Barakat M, Aloreidi K, Gujjula S, et al. Overutilization of Fecal Occult Blood Test in the Acute Hospital Setting and its Impact on Clinical Management and Outcomes. Gastroenterology. 2020;159(2):e21-e22. doi:10.1053/j.gastro.2020.06.059
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Negative PillSense™ for Safe Discharge in Patients With Positive Hemoccult and/or Unexplained Anemia
- ClinicalTrials.gov ID
- NCT06951490
- Acronym / sponsor ID
- PillSense™ / 2232176
- Keywords
- PillSense, Upper Gastrointestinal Bleeding, GI Bleed Detection, Positive Hemoccult, Capsule Endoscopy, Non-invasive Diagnostics, Real-time GI Bleed Detection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- EnteraSense Limited
- Study start
- 15 May 2025 (actual)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, participants will be offered a PillSense™ capsule, a small capsule to swallow, which can detect the presence of blood in the upper digestive tract within about 10 minutes. The results of this capsule test will not alter the current care plan but will help us assess whether PillSense™ can be used in the future as a standalone test to determine if it is safe for patients to be discharged with anemia or a positive stool test without other signs of gastrointestinal bleeding. This study aims to collect data that will help determine if the PillSense™ capsule could one day reduce the need for more invasive procedures while hospitalized, like endoscopy, and ensure safe patient discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients Undergoing PillSense™ Testing | – | Device: PillSense™This group includes hospitalized adult patients who have been referred to gastroenterology services for unexplained anemia and/or a positive fecal occult blood test (hemoccult) in the absence of overt gastrointestinal bleeding (e.g., no melena, hematemesis, or hematochezia). All participants will ingest the PillSense™ capsule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PillSense™The PillSense™ System is a prescription only device consisting of a reusable receiver and single-use ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract. | Device | Hospitalized Patients Undergoing PillSense™ Testing |
Primary outcome
Accuracy of Negative PillSense™ Result in Predicting Safe Discharge
Time frame: 24 hours
To measure the percentage of participants with a negative Pillsense™ result who are safely discharged from the hospital without requiring urgent endoscopic intervention or experiencing adverse events during their hospitalization.
5 secondary outcomes
False Negative Rate of PillSense™
Time frame: During hospitalization (up to 72 hours after capsule ingestion)
Timing of Endoscopic Intervention
Time frame: 24-72 hours
Length of Hospital Stay
Time frame: 24-72 hours
30-Day Readmission Rate
Time frame: 30 days post-discharge
30-Day Mortality
Time frame: 30 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 28253209Yung DE, Plevris JN, Koulaouzidis A. Short article: Aspiration of capsule endoscopes: a comprehensive review of the existing literature. Eur J Gastroenterol Hepatol. 2017 Apr;29(4):428-434. doi: 10.1097/MEG.0000000000000821.
- Background: PubMed 28815031Nemeth A, Wurm Johansson G, Nielsen J, Thorlacius H, Toth E. Capsule retention related to small bowel capsule endoscopy: a large European single-center 10-year clinical experience. United European Gastroenterol J. 2017 Aug;5(5):677-686. doi: 10.1177/2050640616675219. Epub 2016 Oct 16.
- Background: PubMed 20173646Rondonotti E, Soncini M, Girelli C, Ballardini G, Bianchi G, Brunati S, Centenara L, Cesari P, Cortelezzi C, Curioni S, Gozzini C, Gullotta R, Lazzaroni M, Maino M, Mandelli G, Mantovani N, Morandi E, Pansoni C, Piubello W, Putignano R, Schalling R, Tatarella M, Villa F, Vitagliano P, Russo A, Conte D, Masci E, de Franchis R; AIGO, SIED and SIGE Lombardia. Small bowel capsule endoscopy in clinical practice: a multicenter 7-year survey. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1380-6. doi: 10.1097/MEG.0b013e3283352ced.
- Background: PubMed 26473123Lim YJ, Lee OY, Jeen YT, Lim CY, Cheung DY, Cheon JH, Ye BD, Song HJ, Kim JS, Do JH, Lee KJ, Shim KN, Chang DK, Park CH, Jang BI, Moon JS, Chun HJ, Choi MG, Kim JO; Korean Gut Image Study Group. Indications for Detection, Completion, and Retention Rates of Small Bowel Capsule Endoscopy Based on the 10-Year Data from the Korean Capsule Endoscopy Registry. Clin Endosc. 2015 Sep;48(5):399-404. doi: 10.5946/ce.2015.48.5.399. Epub 2015 Sep 30.
- Background: PubMed 20152309Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
- Background: PubMed 26671587Fernandez-Urien I, Carretero C, Gonzalez B, Pons V, Caunedo A, Valle J, Redondo-Cerezo E, Lopez-Higueras A, Valdes M, Menchen P, Fernandez P, Munoz-Navas M, Jimenez J, Herrerias JM. Incidence, clinical outcomes, and therapeutic approaches of capsule endoscopy-related adverse events in a large study population. Rev Esp Enferm Dig. 2015 Dec;107(12):745-52. doi: 10.17235/reed.2015.3820/2015.
- Background: PubMed 28069475Rezapour M, Amadi C, Gerson LB. Retention associated with video capsule endoscopy: systematic review and meta-analysis. Gastrointest Endosc. 2017 Jun;85(6):1157-1168.e2. doi: 10.1016/j.gie.2016.12.024. Epub 2017 Jan 6.
- Background: PubMed 17963875Sachdev MS, Leighton JA, Fleischer DE, Heigh RI, Hara AK, Post JA, Erickson PJ, Sharma VK. A prospective study of the utility of abdominal radiographs after capsule endoscopy for the diagnosis of capsule retention. Gastrointest Endosc. 2007 Nov;66(5):894-900. doi: 10.1016/j.gie.2007.06.066.
- Background: PubMed 38065512Akiki K, Mahmoud T, Alqaisieh MH, Sayegh LN, Lescalleet KE, Abu Dayyeh BK, Wong Kee Song LM, Larson MV, Bruining DH, Coelho-Prabhu N, Buttar NS, Sedlack RE, Chandrasekhara V, Leggett CL, Law RJ, Rajan E, Gleeson FC, Alexander JA, Storm AC. A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial. Gastrointest Endosc. 2024 May;99(5):712-720. doi: 10.1016/j.gie.2023.11.051. Epub 2023 Dec 6.
- Background: PubMed 15644385Niv E, Elis A, Zissin R, Naftali T, Novis B, Lishner M. Iron deficiency anemia in patients without gastrointestinal symptoms--a prospective study. Fam Pract. 2005 Feb;22(1):58-61. doi: 10.1093/fampra/cmh705. Epub 2005 Jan 11.
- Background: PubMed 16785199Stray N, Weberg R. A prospective study of same day bi-directional endoscopy in the evaluation of patients with occult gastrointestinal bleeding. Scand J Gastroenterol. 2006 Jul;41(7):844-50. doi: 10.1080/00365520500495789.
- Background: PubMed 18725159Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
- Individual participant dataSharing planned: No. We will not be sharing information from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occult Gastrointestinal Bleeding and Upper Gastrointestinal Bleeding (UGIB), run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Negative PillSense™ Result in Predicting Safe Discharge (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951490, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.