Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING] (DING)
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|ClinicalTrials.gov Identifier: NCT03176407|
Recruitment Status : Completed
First Posted : June 5, 2017
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Upper GI Bleeding||Diagnostic Test: HemoPill acute||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||There is only one patient group. The one that swallow the sensor capsule.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule: A Pilot Study [DING]|
|Actual Study Start Date :||April 11, 2015|
|Actual Primary Completion Date :||February 24, 2016|
|Actual Study Completion Date :||February 29, 2016|
Experimental: HemoPill acute
Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours.
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.
Diagnostic Test: 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.
- Number of Participants With (Serious) Adverse Event Related to the Medical Device [ Time Frame: 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.
- 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.
- 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176407
|Department of Gastroenterology and Oncology, Klinikum Ludwigsburg|
|Study Director:||Thomas Gottwald, Prof. Dr.||Ovesco Endoscopy AG|