Trial Outcomes & Findings for Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING] (NCT NCT03176407)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

until capsule excretion happened, an average of 10 days

Results posted on

2019-10-10

Participant Flow

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).

Participant milestones

Participant milestones
Measure	HemoPill Acute There was only one study arm as all patients swallowed the sensor capsule.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	HemoPill Acute There was only one study arm as all patients swallowed the sensor capsule.
Overall Study Protocol Violation	1
Overall Study human failure	1
Overall Study EGD showed esophageal varices=excl. crit	1

Baseline Characteristics

Due to the fact that n = 3 dropouts occured.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HemoPill Acute n=27 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants • Due to the fact that n = 3 dropouts occured.
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants • Due to the fact that n = 3 dropouts occured.
Age, Categorical >=65 years	19 Participants n=99 Participants • Due to the fact that n = 3 dropouts occured.
Age, Continuous	66 years n=99 Participants • Due to protocol violations there were n=3 lost to folllow-up patients that were not included in the analysis.
Sex: Female, Male Female	10 Participants n=99 Participants • Due to protocol violations there were n=3 lost to folllow-up patients that were not included in the analysis.
Sex: Female, Male Male	17 Participants n=99 Participants • Due to protocol violations there were n=3 lost to folllow-up patients that were not included in the analysis.
Region of Enrollment Germany	27 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HemoPill Acute n=30 Participants Capsule is swallowed by the patients themselves. Patient takes the capsule in their hands and put it in their mouth and swallow it by themselves.
Number of Participants With (Serious) Adverse Event Related to the Medical Device	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HemoPill Acute n=30 Participants Capsule is swallowed by the patients themselves. Patient takes the capsule in their hands and put it in their mouth and swallow it by themselves.
Number of Participants With Device Deficiencies	0 Participants

PRIMARY outcome

Timeframe: until capsule excretion happened, an average of 10 days

Population: One human failure occured.

Human failures that appear during the capsule application or data readout.

Outcome measures

Outcome measures
Measure	HemoPill Acute n=30 Participants Capsule is swallowed by the patients themselves. Patient takes the capsule in their hands and put it in their mouth and swallow it by themselves.
Number of Participants With Human Failures in Capsule Application	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HemoPill Acute n=30 Participants Capsule is swallowed by the patients themselves. Patient takes the capsule in their hands and put it in their mouth and swallow it by themselves.
Number of Participants With Sensor Capsule Ingestion Problems	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HemoPill Acute n=30 Participants Capsule is swallowed by the patients themselves. Patient takes the capsule in their hands and put it in their mouth and swallow it by themselves.
Number of Patients Which do Not Accept the Medical Device, Measured in Numbers	0 Participants

Adverse Events

HemoPill Acute

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. T. Gottwald

Ovesco Endoscopy AG

Phone: 0049707196528

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place