Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)

GERD Clinical Trial

Official title:

Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01551095
• Other study ID #: NA_00048369
• Status: Terminated
• Phase: Phase 2
• First received: February 29, 2012
• Last updated: June 28, 2013
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: June 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• GERD

Intervention

Device:
• PEGJ tube
The self-propelled PEGJ feeding tube

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	GI Supply

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Number of Participants with Adverse Events	Complications as a result of the PEGJ will be assessed (pain, vomiting, nausea)	From date of PEGJ placement up to 3 weeks	Yes
Secondary	Migration of PEGJ feeding tube	Risk of retrograde migration within 3 weeks of placement	From date of PEGJ placement up to 3 weeks	No