GERDPhase 2NCT01551095
Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)
A Phase 2 study testing PEGJ tube in people with GERD, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- GERD
- What is being tested?
- PEGJ tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-90 years
- 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 for the study
Who cannot join
- patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000)
- inability to get informed consent for the study from patients or their families
- pregnancy (all women of child-bearing age will undergo urine pregnancy testing)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study
This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach.
Read the detailed description
The word "investigational" means the PEGJ feeding tube used in this study is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies. Currently commercially available PEGJ tubes are long tubes which are placed into the part of the small intestine that connects to the stomach (duodenum) under endoscopic guidance. The tip of these PEGJ tubes usually have some built-in extra weight (several grams), which theoretically should prevent slippage of the tube back into the stomach. However, these tubes usually cannot be placed very far into the duodenum and the build-in weight is usually not sufficient to keep the tube in place.
The tip of the currently commercially available PEGJ tubes often (usually within 1-2 weeks) migrates back into the stomach and at that point the tube needs to be replaced. The investigational PEGJ feeding tube used in this study is self-propelled and has a balloon on its tip. The tip of this tube is directed endoscopically through the part of the stomach that connects to the duodenum (pylorus), then the balloon is filled with 5 cc of water and the endoscope is removed. The water filled balloon then is carried by the movement of the intestinal muscles through the duodenum into the middle section of the small intestine (jejunum). It is hoped that such a deep position of the tip of the self-propelled PEGJ tube and presence of the water-filled balloon on its tip will prevent migration of the tube back into the stomach and therefore eliminates the need for tube replacement.
The only difference between the currently approved PEGJ feeding tube and the investigational one being used in this study is the addition of the balloon to the tip of the J port. People who come to Johns Hopkins Hospital for PEGJ placement as part of standard clinical care and who are not pregnant may join the study.
- Conditions
- GERD
- Being tested
- PEGJ tube
- Keywords
- PEGJ, PEG-J, percutaneous endoscopic gastrostomy, feeding tube, gastroparesis, acute pancreatitis, stroke, respiratory failure, GERD, balloon, self-propelled
- Medical subject headings
- Gastroesophageal Reflux, Gastroparesis, Pancreatitis, Stroke, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGJ tubeDevice
The self-propelled PEGJ feeding tube
| Study group | Role | What they receive |
|---|---|---|
| PEGJ | Experimental | Patients in this arm will receive self-propelled balloon PEGJ tube. Receives: Device: PEGJ tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants With Adverse Events
One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.
Measured: From date of PEGJ placement up to 3 weeks
Secondary outcomes (1)
Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement
An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.
Measured: From date of PEGJ placement up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Proof of principle was achieved after inclusion of 7 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- GI Supply
- Responsible party
- Principal investigator, Mouen Khashab, Johns Hopkins University
- Investigators
- Mouen Khashab, MD, Principal investigator, Johns Hopkins Hospital Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551095
- Sponsor's protocol ID
- NA_00048369
- Status last verified
- Mar 2017
- First submitted
- 29 Feb 2012
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kim KJ, Victor D, Stein E, Valeshabad AK, Saxena P, Singh VK, Lennon AM, Clarke JO, Khashab MA. A novel ballooned-tip percutaneous endoscopic gastrojejunostomy tube: a pilot study. Gastrointest Endosc. 2013 Jul;78(1):154-7. doi: 10.1016/j.gie.2013.03.005. Epub 2013 Apr 24.
PubMed 23622977
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study
- ClinicalTrials.gov ID
- NCT01551095
- Acronym / sponsor ID
- NA_00048369
- Conditions
- GERD
- Keywords
- PEGJ, PEG-J, percutaneous endoscopic gastrostomy, feeding tube, gastroparesis, acute pancreatitis, stroke, respiratory failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Proof of principle was achieved after inclusion of 7 patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- GI Supply
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 12 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach.
Detailed description
The word "investigational" means the PEGJ feeding tube used in this study is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies. Currently commercially available PEGJ tubes are long tubes which are placed into the part of the small intestine that connects to the stomach (duodenum) under endoscopic guidance. The tip of these PEGJ tubes usually have some built-in extra weight (several grams), which theoretically should prevent slippage of the tube back into the stomach. However, these tubes usually cannot be placed very far into the duodenum and the build-in weight is usually not sufficient to keep the tube in place.
The tip of the currently commercially available PEGJ tubes often (usually within 1-2 weeks) migrates back into the stomach and at that point the tube needs to be replaced. The investigational PEGJ feeding tube used in this study is self-propelled and has a balloon on its tip. The tip of this tube is directed endoscopically through the part of the stomach that connects to the duodenum (pylorus), then the balloon is filled with 5 cc of water and the endoscope is removed. The water filled balloon then is carried by the movement of the intestinal muscles through the duodenum into the middle section of the small intestine (jejunum). It is hoped that such a deep position of the tip of the self-propelled PEGJ tube and presence of the water-filled balloon on its tip will prevent migration of the tube back into the stomach and therefore eliminates the need for tube replacement.
The only difference between the currently approved PEGJ feeding tube and the investigational one being used in this study is the addition of the balloon to the tip of the J port. People who come to Johns Hopkins Hospital for PEGJ placement as part of standard clinical care and who are not pregnant may join the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEGJ | Experimental | Device: PEGJ tubePatients in this arm will receive self-propelled balloon PEGJ tube. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-90 years
- 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 for the study
Key exclusion criteria (3 listed)
- patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000)
- inability to get informed consent for the study from patients or their families
- pregnancy (all women of child-bearing age will undergo urine pregnancy testing)
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 |
|---|---|---|
| PEGJ tubeThe self-propelled PEGJ feeding tube | Device | PEGJ |
Primary outcome
Safety: Number of Participants With Adverse Events
Time frame: From date of PEGJ placement up to 3 weeks
One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.
1 secondary outcome
Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement
Time frame: From date of PEGJ placement up to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23622977Kim KJ, Victor D, Stein E, Valeshabad AK, Saxena P, Singh VK, Lennon AM, Clarke JO, Khashab MA. A novel ballooned-tip percutaneous endoscopic gastrojejunostomy tube: a pilot study. Gastrointest Endosc. 2013 Jul;78(1):154-7. doi: 10.1016/j.gie.2013.03.005. Epub 2013 Apr 24.
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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.
Mouen Khashab, MD principal investigator
Johns Hopkins Hospital Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEGJ tube in people with GERD, run by Johns Hopkins University at 1 site in United States.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants With Adverse Events (time frame: From date of PEGJ placement up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551095, which also lists 1 linked publication.
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 Mar 2017.