Status unknownNCT02609620PFTUpdated Dec 31, 2015

Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube

An interventional study of Peristaltic Feeding Tube and ConvaTec Levin Duodenal Tube in Gastro-esophageal Reflux, sponsored by LunGuard Ltd.. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-12-31.

Sponsored by LunGuard Ltd. · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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 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 studied

Gastro-esophageal Reflux

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Gastroesophageal Reflux 1,067

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

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Lead sponsor

This is the only study on the registry with LunGuard Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

- 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
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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
Treatment
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
Device: Peristaltic Feeding Tube
Active comparator
Control
Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard.
Device: ConvaTec Levin Duodenal Tube

Interventions

DevicePeristaltic Feeding Tube
DeviceConvaTec Levin Duodenal Tube

What researchers measure

Primary outcomes

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

Secondary outcomes

Reduction of ventilator associated pneumonia (VAP)
Time frame: 12-24 hours
Reduction of micro-aspirations
Time frame: 12-24 hours

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02609620
Lead sponsor: LunGuard Ltd.
Responsible party: Sponsor
First posted: Nov 20, 2015
Start date: Dec 2015
Primary completion: Jun 2016 (estimated)
Completion: Oct 2016 (estimated)
Last update: Dec 31, 2015

Study contacts

Adi Ickowicz

Contact

adi@medicsense.com

+97239233666 ext. 0

Gilat Mor

Contact

gilat@medicasense.com

+97239233666 ext. 4

Philip Biderman, MD

principal investigator · Bellinson Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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