Back to results

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

Primary Purpose

Upper GI Bleeding

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

HemoPill acute

About this trial

This is an interventional device feasibility trial for Upper GI Bleeding focused on measuring sensor capsule

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Gastroenterology and Oncology, Klinikum Ludwigsburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HemoPill acute

Arm Description

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.

Outcomes

Primary Outcome Measures

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. 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

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

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

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03176407

First Posted

April 21, 2017

Last Updated

September 20, 2019

Sponsor

Ovesco Endoscopy AG

1. Study Identification

Unique Protocol Identification Number

NCT03176407

Brief Title

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

Acronym

DING

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

April 11, 2015 (Actual)

Primary Completion Date

February 24, 2016 (Actual)

Study Completion Date

February 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ovesco Endoscopy AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper GI Bleeding

Keywords

sensor capsule

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

There is only one patient group. The one that swallow the sensor capsule.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HemoPill acute

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

HemoPill acute

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With (Serious) Adverse Event Related to the Medical Device

Description

Time Frame

until capsule excretion happened, an average of 10 days

Title

Number of Participants With Device Deficiencies

Description

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

Title

Number of Participants With Human Failures in Capsule Application

Description

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

Time Frame

until capsule excretion happened, an average of 10 days

Title

Number of Participants With Sensor Capsule Ingestion Problems

Description

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

Title

Number of Patients Which do Not Accept the Medical Device, Measured in Numbers

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Gottwald, Prof. Dr.

Organizational Affiliation

Ovesco Endoscopy AG

Official's Role

Study Director

Facility Information:

Facility Name

Department of Gastroenterology and Oncology, Klinikum Ludwigsburg

City

Ludwigsburg

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31157295

Citation

Schmidt A, Zimmermann M, Bauder M, Kuellmer A, Caca K. Novel telemetric sensor capsule for EGD urgency triage: a feasibility study. Endosc Int Open. 2019 Jun;7(6):E774-E781. doi: 10.1055/a-0880-5312. Epub 2019 May 17.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs