Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)

NCT01551095 | Terminated Phase 2 Results DMC

• 1 other identifier: NA_00048369
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

GERD

Keywords

PEGJ; PEG-J; percutaneous endoscopic gastrostomy; feeding tube; gastroparesis; acute pancreatitis; stroke; respiratory failure; GERD; balloon; self-propelled

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From date of PEGJ placement up to 3 weeks

Study Arms (1)

PEGJ

EXPERIMENTAL

Patients in this arm will receive self-propelled balloon PEGJ tube.

Device: PEGJ tube

Interventions

PEGJ tube DEVICE

The self-propelled PEGJ feeding tube

PEGJ

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• GI Supply: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 23622977 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Gastroparesis; Pancreatitis; Stroke; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

Small number of patients and short follow-up

Results Point of Contact

• Title: Mouen Khashab
• Organization: Johns Hopkins University

mkhasha1@jhmi.edu

443-287-1960

Study Officials

• Mouen Khashab, MD

  Johns Hopkins Hospital Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 12, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 31, 2017
• Results First Posted: October 12, 2016

Record last verified: 2017-03

Locations

US (1)