NCT01892267

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 6, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

July 1, 2013

Results QC Date

August 19, 2016

Last Update Submit

April 13, 2017

Conditions

Feeding Tube

Keywords

PEGJPEG-JPercutaneous Endoscopic GastrostomyFeeding tubeGastroparesisAcute pancreatitisStrokeRespiratory failureGERDBalloonSelf-propelled

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With PEG-J Tube Migration

    Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.

    From date of placement up to 4 weeks

Secondary Outcomes (10)

  • Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration

    4 weeks

  • Patency of Feeding Tube

    2 years

  • Technical Success

    Intra-procedural

  • Intervention Time

    Intra-procedural

  • Time to Repeat Endoscopy for Tube Replacement

    2 years

  • +5 more secondary outcomes

Study Arms (2)

Self-propelled PEGJ feeding tube

EXPERIMENTAL

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

Device: PEG-J placement

Standard PEGJ feeding tube

ACTIVE COMPARATOR

Patients in this arm will receive the standard commercially availabel PEGJ tube.

Device: PEG-J placement

Interventions

PEG-J placementDEVICE

PEG-J placement

Self-propelled PEGJ feeding tubeStandard PEGJ feeding tube

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 23622977BACKGROUND

MeSH Terms

Conditions

GastroparesisPancreatitisStrokeRespiratory InsufficiencyGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPancreatic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal Diseases

Results Point of Contact

Title
Dr. Mouen Khashab
Organization
Johns Hopkins Hospital
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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 4, 2013

Study Start

September 6, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 17, 2017

Results First Posted

May 17, 2017

Record last verified: 2017-04

Locations

US(1)