UGI Bleed, Upper Gastrointestinal Bleed, Upper Gastrointestinal Bleeding
Conditions
Keywords
EnteraSense, PillSense, UGI Bleed, UGIB, Upper Gastrointestinal Bleeding, Upper Gastrointestinal Bleed, Upper Gastrointestinal
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTPillSense
The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Sponsors
Databean
EnteraSense Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years * Ability to provide informed consent * Clinical suspicion of UGIB
Exclusion criteria
* Circulatory or hemodynamic instability * Known GI tract stricture * Using an implantable electrical device * Difficulties in swallowing pills the size of the capsule * History of: achalasia or known esophageal dysmotility; gastroparesis; severe constipation; Crohn's disease; bowel obstruction * Currently taking medications intended for stimulation of GI motility * Currently pregnant or breastfeeding, or intend to become pregnant during the investigation * Suspected or previously diagnosed obstructing gastrointestinal tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Day 1 | 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. |
| Specificity | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NPV | Day 1 | 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. |
| Transit | Day 1 through Day 14 | 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. |
| PPV | Day 1 | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects enrolled between December 10, 2021 and August 18, 2022 at the Mayo Clinic, Rochester, MN.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 126 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet study criteria | 1 |
| Overall Study | Unable to swallow capsule | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | PillSense (Active) |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 117 Participants |
| Region of Enrollment United States | 126 participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 126 |
| other Total, other adverse events | 9 / 126 |
| serious Total, serious adverse events | 15 / 126 |
Outcome results
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.
Time frame: Day 1
Population: modified Intent to Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillSense (Active) | Sensitivity | 26 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.
Time frame: Day 1
Population: modified Intent to Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillSense (Active) | Specificity | 87 Participants |
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.
Time frame: Day 1
Population: True Negatives + False Negatives
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillSense (Active) | NPV | 87 Participants |
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.
Time frame: Day 1
Population: True Positives + False Positives
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillSense (Active) | PPV | 26 Participants |
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.
Time frame: Day 1 through Day 14
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PillSense (Active) | Transit | 3.6 days | Standard Deviation 2.35 |