Gastro-esophageal RefluxPFTNCT02609620
Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube
A study testing Peristaltic Feeding Tube and ConvaTec Levin Duodenal Tube in people with Gastro-esophageal Reflux, run by LunGuard Ltd..
Trial summary
This study is designated to test the safety and initial efficacy of the LunGuard's PFT device for reduction of GER. Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastro-esophageal Reflux
- What is being tested?
- Peristaltic Feeding Tube and ConvaTec Levin Duodenal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent.
- Patients who are expected for at least 12 hours to be:
- Mechanically ventilated and sedated.
- Requiring a nasogastric tube.
- Included are:
- Patients who have undergone tracheostomy.
- Patients who require use of pro-kinetic drugs and proton pump inhibitors.
- All levels of Gastric Residual Volume (GRV)
Who cannot join
- • Patients with a contraindication for insertion of a nasogastric tube.
- Patients with a known esophageal obstruction, preventing passage of the device.
- Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor GERD patients)
- Acute and severe coagulation disorders
- (INR> 2 or platelets below 30,000)
- Diabetic patients with documented gastrointestinal neuropathy
Show all 9Show fewer
- Pregnancy or lactation
- Allergy to Silicon
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-Center, Open Label, Randomized, Controlled Study to Evaluate the Safety & Initial Efficacy of the LunGuard PFT System, and Its Impact on GER in Enteral-Fed, Sedated and Mechanically Ventilated Critically Ill Patients
This study is designated to test the safety and initial efficacy of the LunGuard's PFT device for reduction of GER.
Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction on predetermined intervals and analysed for Pepsin A concentration.
The PFT will be removed upon completion of the study's scheduled routine. Patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard.
- Conditions
- Gastro-esophageal Reflux
- Being tested
- Peristaltic Feeding Tube, ConvaTec Levin Duodenal Tube
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peristaltic Feeding TubeDevice
ConvaTec Levin Duodenal TubeDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | In the treatment group: The LunGuard Peristaltic Feeding Tube (PFT) will be positioned in the ICU and positioning will be verified by X-ray. Nutritional formula will be fed into the stomach via the feeding lumen of the PFT Receives: Device: Peristaltic Feeding Tube |
| Control | Active comparator | Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard. Receives: Device: ConvaTec Levin Duodenal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of gastro-esophageal reflux (GER) by 30%
Measured: 12-24 hours
Continuous esophageal pressure monitoring
Measured: 12-24 hours
Successful introduction, positioning and removal of the device
Measured: 12-24 h
Successful enteral feeding
Measured: 12-24 hours
Secondary outcomes (2)
Reduction of ventilator associated pneumonia (VAP)
Measured: 12-24 hours
Reduction of micro-aspirations
Measured: 12-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LunGuard Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Biderman, MD, Principal investigator, Bellinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609620
- Sponsor's protocol ID
- PROT-150630835CTIL
- Acronym
- PFT
- Status last verified
- Dec 2015
- First submitted
- 17 Nov 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open Label, Randomized, Controlled Study to Evaluate the Safety & Initial Efficacy of the LunGuard PFT System, and Its Impact on GER in Enteral-Fed, Sedated and Mechanically Ventilated Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02609620
- Acronym / sponsor ID
- PFT / PROT-150630835CTIL
- Conditions
- Gastro-esophageal Reflux
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- LunGuard Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designated to test the safety and initial efficacy of the LunGuard's PFT device for reduction of GER.
Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction on predetermined intervals and analysed for Pepsin A concentration.
The PFT will be removed upon completion of the study's scheduled routine. Patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Peristaltic Feeding TubeIn the treatment group: The LunGuard Peristaltic Feeding Tube (PFT) will be positioned in the ICU and positioning will be verified by X-ray. Nutritional formula will be fed into the stomach via the feeding lumen of the PFT |
| Control | Active comparator | Device: ConvaTec Levin Duodenal TubePatients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent.
- Patients who are expected for at least 12 hours to be:
- Included are:
Key exclusion criteria (9 listed)
- • Patients with a contraindication for insertion of a nasogastric tube.
- Patients with a known esophageal obstruction, preventing passage of the device.
- Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor GERD patients)
- Acute and severe coagulation disorders
- (INR> 2 or platelets below 30,000)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peristaltic Feeding Tube | Device | Treatment |
| ConvaTec Levin Duodenal Tube | Device | Control |
Primary outcome
Reduction of gastro-esophageal reflux (GER) by 30%
Time frame: 12-24 hours
Continuous esophageal pressure monitoring
Time frame: 12-24 hours
Successful introduction, positioning and removal of the device
Time frame: 12-24 h
Successful enteral feeding
Time frame: 12-24 hours
2 secondary outcomes
Reduction of ventilator associated pneumonia (VAP)
Time frame: 12-24 hours
Reduction of micro-aspirations
Time frame: 12-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
Related trials for Gastro-esophageal Reflux
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Gastro Esophageal Reflux
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Biderman, MD principal investigator
Bellinson Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Peristaltic Feeding Tube and ConvaTec Levin Duodenal Tube in people with Gastro-esophageal Reflux, run by LunGuard Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adi Ickowicz (+97239233666 ext. 0, adi@medicsense.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of gastro-esophageal reflux (GER) by 30% (time frame: 12-24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.