TerminatedPhase 2

Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT

Stopped: Study was terminated prematurely as costs incurred were more than the available funds.

United States19 participantsStarted 2013-09-06

Plain-language summary

Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard PEGJ feeding tubes.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive adult patients (18-80 years of age) with need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc). * Ability to give informed consent. Exclusion Criteria: * Unable to give informed consent * Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) * Acute gastrointestinal bleeding * Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), on chronic anticoagulation, or platelet count \<50,000 * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy * Cirrhosis with portal hypertension, varices, and/or ascites * Allergy to egg

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With PEG-J Tube Migration

Timeframe: From date of placement up to 4 weeks

Trial details

NCT IDNCT01892267

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2016-08-19

View on ClinicalTrials.gov More Feeding Tube trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.