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| Name | Class |
|---|---|
| Databean | INDUSTRY |
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This is a prospective, non-randomized, open-label clinical investigation to evaluate feasibility, effectiveness and safety of the PillSense System, the transit of the PillSense Capsule through the GI tract, patient tolerability of the PillSense Capsule, and blood detection.
Patient eligibility as set out in the inclusion/exclusion criteria for the clinical investigation will be reviewed prior to study enrollment. Prior to administering the PillSense Capsule, the PillSense Receiver will be paired with the PillSense Capsule. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message "Blood detected" or "No Blood detected". The overall investigation from the PillSense Capsule activation and ingestion until the result message is displayed takes less than 10 minutes. Esophagogastroduodenoscopy (EGD) should be completed immediately or up to 4 hours after PillSense Capsule administration in each patient that receives a "Blood detected" or "No blood detected" result to confirm the result achieved with the PillSense System. The endoscopy will be conducted according to the site's standard of care. Prior to discharge each patient will undergo an X-Ray examination to evaluate for PillSense Capsule presence. Following discharge, if there is no verifiable evidence that the PillSense Capsule passed through the gastrointestinal tract (GIT) (such as a photograph of stool with capsule in it or photograph of the capsule alone), the patient may undergo an X-Ray examination at Day 7 ± 5 days and, if necessary, at Day 14± 7 days to ascertain the passage status of the PillSense Capsule. If the PillSense Capsule did not pass through the GIT, it should be removed by an endoscopic method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PillSense (Active) | Experimental | This is a single-arm, non-randomized study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillSense | Diagnostic Test | The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | To assess the sensitivity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Sensitivity = True Positives / (True Positives + False Negative). True positives were observations of bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)]. False negatives were observation of bleed not detected via capsule but EGD confirmed bleed. | Day 1 |
| Specificity | To evaluate the specificity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Specificity=True Negatives / (True Negatives + False Positive). True negatives were observations of no bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)]. False positives were observation of bleed detected via capsule but EGD confirmed no bleed. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| NPV | Negative predictive value (NPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". | Day 1 |
| Transit |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Collins | Technical Operations Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38065512 | Derived | Akiki 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. |
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Subjects enrolled between December 10, 2021 and August 18, 2022 at the Mayo Clinic, Rochester, MN.
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| ID | Title | Description |
|---|---|---|
| FG000 | PillSense (Active) | This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | PillSense (Active) | This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity | To assess the sensitivity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Sensitivity = True Positives / (True Positives + False Negative). True positives were observations of bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)]. False negatives were observation of bleed not detected via capsule but EGD confirmed bleed. | modified Intent to Treat | Posted | Count of Participants | Participants | Day 1 |
|
From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days).
Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PillSense (Active) | This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideations | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Collins, Director of Technical Operations | EnteraSense Ltd. | 091 750 246 | david@enterasense.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2022 | Sep 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2022 | Sep 7, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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To evaluate the transit of the PillSense Capsule through the GI tract. Passage of the capsule will be monitored until capsule has passed from the body. If subject or study team is unable to determine capsule passage visually, a confirmation x-ray or other imaging will be used to determine if the capsule is still present in the body.
| Day 1 through Day 14 |
| PPV | Positive predictive value (PPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". | Day 1 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Specificity | To evaluate the specificity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Specificity=True Negatives / (True Negatives + False Positive). True negatives were observations of no bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)]. False positives were observation of bleed detected via capsule but EGD confirmed no bleed. | modified Intent to Treat | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | NPV | Negative predictive value (NPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". | True Negatives + False Negatives | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Transit | To evaluate the transit of the PillSense Capsule through the GI tract. Passage of the capsule will be monitored until capsule has passed from the body. If subject or study team is unable to determine capsule passage visually, a confirmation x-ray or other imaging will be used to determine if the capsule is still present in the body. | Safety Population | Posted | Mean | Standard Deviation | days | Day 1 through Day 14 |
|
|
|
| Secondary | PPV | Positive predictive value (PPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". | True Positives + False Positives | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 126 |
| 15 |
| 126 |
| 9 |
| 126 |
| Alchohol withdrawal seizure | Social circumstances | Systematic Assessment |
|
| Abdominal Distention / Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | Systematic Assessment |
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| Chest Pain with SOB | Cardiac disorders | Systematic Assessment |
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| Acute Limb Ischemia | Vascular disorders | Systematic Assessment |
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| Amyloidosis and Multiple Myeloma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hemobilia | Hepatobiliary disorders | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Failure to extubate | Surgical and medical procedures | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Lethargy | General disorders | Systematic Assessment |
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| Lumbar Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Epistasix | Ear and labyrinth disorders | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |