Upper GI Bleeding
Conditions
Keywords
sensor capsule
Brief summary
The clinical trial entitled Detection of upper gastrointestinal (GI) bleeding with a novel bleeding sensor capsule - a pilot study was carried out in a monocentric clinical trial with 30 patients. This trial aimed to determine if the capsule's sensor signals allow to deduct the patient's bleeding status in a clinical setting. The target of the explorative study was to show the feasibility and safety of the HemoPill acute and its implementation procedure as well as, the definition of measurable parameters and thresholds for blood detection. Within this clinical trial, initial clinical data on the performance of the HemoPill acute capsule were collected.
Detailed description
The clinical trial entitled Detection of upper gastrointestinal (GI) bleeding with a novel bleeding sensor capsule - a pilot study was carried out in a monocentric clinical trial with 30 patients as part of the final development phase of the HemoPill acute, a bleeding sensor capsule. The swallowable capsule operates with the combination of an optical sensor for blood detection positioned within a recess in the capsule surface and a radio interface for wireless transmission of sensor data to an external receiver device. The HemoPill acute capsule is used for diagnosis of patients with suspected acute upper gastrointestinal bleeding. For the study, the HemoPill acute capsule was swallowed by the patient and a special extracorporeal receiver was positioned next to the patient's body. The receiver recorded sensor signals from the ingested capsule for the next 4 hours. Patients who had swallowed a capsule underwent endoscopy within the next 12 hours. Later, both the endoscopic pictures and the endoscopy report were compared to the sensor capsule data recorded in the extracorporeal receiver. Furthermore, the excretion of each HemoPill acute capsule was monitored in accordance with the study protocol (regular check to see if sensor signal was still detectable from inside the patient's body) for a follow-up period of 10 days.
Interventions
DIAGNOSTIC_TESTHemoPill acute
Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours. Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days.
Sponsors
Ovesco Endoscopy AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
There is only one patient group. The one that swallow the sensor capsule.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* clinical suspicion based on anamnestic statements and clinical symptom * vomiting of hematin (coffee-ground-like material) * hematemesis * melena (anamnestic or digital rectal evidence) * attentive and conscious patient * written informed consent, age ≥ 18 years and ≤ 80 years
Exclusion criteria
* circulatory instability (with a clear need for urgent endoscopy) * cases which required urgently surgical therapy, e.g. patients previously treated endoscopically because of GI bleeding and with an urgent suspicion of recurrent bleeding, which could not be treated endoscopically because of previous findings as well as patients experiencing re-bleeding after surgery * known and assumed stenosis of the GI tract, e.g. patients with fistulas, malformations and anatomical variability, insufficiencies, adhesions and previous traumas * pacemakers or other implantable electrical devices * difficulties in swallowing pills the size of the capsule known dysphagia (e.g. achalasia, known diverticula of the esophagus etc.) which were inoperable: patients with ASA IV or higher * known and distinct retardation of the gastro-intestinal tract, induced by previous surgeries, stenosis or paralytic ileus with a diagnosed enteritis * moribund patient * pregnancy and breastfeeding * psychological illnesses, which might impair patient cooperation (comprehension problems, informed consent impossible) * stomach bezoar * NSAR-induced enteropathy * known allergies against Parylene (surface coating of the capsule) * peptic esophagitis III an IV * florid M.Crohn or known inflammation-induced strictures * distinct diverticulosis or diverticulitis * suspected gastrointestinal tumor disease * necessity of MRI investigation * heavy genetic bleeding tendency (e.g. factor VIII deficiency) * esophagus varices * class III obesity (BMI ≥ 40) * missing informed consent * age \< 18 years and \> 80 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With (Serious) Adverse Event Related to the Medical Device | until capsule excretion happened, an average of 10 days | In this outcome measure the safety of the sensor capsule is evaluated in relation to the patient application. 1. Every malfunction, failure or characteristic change or performance of the medical device as well as each inappropriate labeling or instruction for use, which can directly or indirectly lead to death or a serious advers event that deteriorates the physical health state of a patient, user or another person. 2. Every technical or medical reason, which are a result of the causes mentioned in No.1 due to the characteristics or performance of the medical device. |
| Number of Participants With Device Deficiencies | until data of the receiver is saved, an average of 2 weeks | All device deficiencies that appear in the study. In this outcome measure the safety and feasibility of the capsule is evaluated. |
| Number of Participants With Human Failures in Capsule Application | until capsule excretion happened, an average of 10 days | Human failures that appear during the capsule application or data readout. |
| Number of Participants With Sensor Capsule Ingestion Problems | at time of capsule ingestion, 1 day | In this outcome measure the feasibility of the capsule is evaluated and if patients have issues on swallowing the sensor capsule in respect to it's size, form or other reasons. |
| Number of Patients Which do Not Accept the Medical Device, Measured in Numbers | at time of study inclusion, 1 day | Patients that have acceptance problems with the sensor capsule in respect to its size, form or other reasons. |
Countries
Germany
Participant flow
Recruitment details
Patients presenting to the emergency department with acute UGIB were screened for eligibility. Inclusion criteria were symptoms suggestive of UGIB defined as hematemesis, coffee ground emesis or melena (at least one of three).
Participants by arm
| Arm | Count |
|---|---|
| HemoPill Acute Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours.
Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | EGD showed esophageal varices=excl. crit | 1 |
| Overall Study | human failure | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | HemoPill Acute |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 66 years |
| Region of Enrollment Germany | 27 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants With Device Deficiencies
All device deficiencies that appear in the study. In this outcome measure the safety and feasibility of the capsule is evaluated.
Time frame: until data of the receiver is saved, an average of 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Acute | Number of Participants With Device Deficiencies | 0 Participants |
Primary
Number of Participants With Human Failures in Capsule Application
Human failures that appear during the capsule application or data readout.
Time frame: until capsule excretion happened, an average of 10 days
Population: One human failure occured.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Acute | Number of Participants With Human Failures in Capsule Application | 1 Participants |
Primary
Number of Participants With Sensor Capsule Ingestion Problems
In this outcome measure the feasibility of the capsule is evaluated and if patients have issues on swallowing the sensor capsule in respect to it's size, form or other reasons.
Time frame: at time of capsule ingestion, 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Acute | Number of Participants With Sensor Capsule Ingestion Problems | 0 Participants |
Primary
Number of Participants With (Serious) Adverse Event Related to the Medical Device
In this outcome measure the safety of the sensor capsule is evaluated in relation to the patient application. 1. Every malfunction, failure or characteristic change or performance of the medical device as well as each inappropriate labeling or instruction for use, which can directly or indirectly lead to death or a serious advers event that deteriorates the physical health state of a patient, user or another person. 2. Every technical or medical reason, which are a result of the causes mentioned in No.1 due to the characteristics or performance of the medical device.
Time frame: until capsule excretion happened, an average of 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Acute | Number of Participants With (Serious) Adverse Event Related to the Medical Device | 0 Participants |
Primary
Number of Patients Which do Not Accept the Medical Device, Measured in Numbers
Patients that have acceptance problems with the sensor capsule in respect to its size, form or other reasons.
Time frame: at time of study inclusion, 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Acute | Number of Patients Which do Not Accept the Medical Device, Measured in Numbers | 0 Participants |