Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING] (DING)

September 20, 2019 updated by: Ovesco Endoscopy AG

Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule: A Pilot Study [DING]

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ludwigsburg, Germany
        • Department of Gastroenterology and Oncology, Klinikum Ludwigsburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.

  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.
until capsule excretion happened, an average of 10 days
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.
until data of the receiver is saved, an average of 2 weeks
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.
until capsule excretion happened, an average of 10 days
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.
at time of capsule ingestion, 1 day
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.
at time of study inclusion, 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ovesco Endoscopy AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Thomas Gottwald, Prof. Dr., Ovesco Endoscopy AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT20-HPA-1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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