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

NCT03176407 | Completed Results

• 1 other identifier: CT20-HPA-1401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper GI Bleeding

Keywords

sensor capsule

Outcome Measures

Primary Outcomes (5)

• 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.

  until capsule excretion happened, an average of 10 days

• 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.

  until data of the receiver is saved, an average of 2 weeks

• Number of Participants With Human Failures in Capsule Application

  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

  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

  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

Study Arms (1)

HemoPill acute

EXPERIMENTAL

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

Interventions

HemoPill acute DIAGNOSTIC_TEST

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.

HemoPill acute

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ovesco Endoscopy AG: lead

Study Sites (1)

Department of Gastroenterology and Oncology, Klinikum Ludwigsburg

Ludwigsburg, Germany

Location

Related Publications (1)

• 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.

  PMID: 31157295 RESULT

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Dr. T. Gottwald
• Organization: Ovesco Endoscopy AG

0049707196528

Study Officials

• Thomas Gottwald, Prof. Dr.

  Ovesco Endoscopy AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: June 5, 2017
• Study Start: April 11, 2015
• Primary Completion: February 24, 2016
• Study Completion: February 29, 2016
• Last Updated: October 10, 2019
• Results First Posted: October 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)