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

This study has been terminated.
(Study was terminated prematurely as costs incurred were more than the available funds.)
Sponsor:
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01892267
First received: July 1, 2013
Last updated: April 13, 2017
Last verified: April 2017
Results First Received: August 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Supportive Care
Condition: Feeding Tube
Intervention: Device: PEG-J placement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled between 7/1/13 and 4/14/14 in an academic tertiary center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Self-propelled PEGJ Feeding Tube

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

PEG-J placement: PEG-J placement

Standard PEGJ Feeding Tube

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

PEG-J placement: PEG-J placement


Participant Flow:   Overall Study
    Self-propelled PEGJ Feeding Tube   Standard PEGJ Feeding Tube
STARTED   9   10 
COMPLETED   9   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Self-propelled PEGJ Feeding Tube

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

PEG-J placement: PEG-J placement

Standard PEGJ Feeding Tube

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

PEG-J placement: PEG-J placement

Total Total of all reporting groups

Baseline Measures
   Self-propelled PEGJ Feeding Tube   Standard PEGJ Feeding Tube   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   10   19 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.22  (13.30)   52  (10.68)   56.84  (12.77) 
Sex/Gender, Customized 
[Units: Participants]
     
Female   4   8   12 
Male   5   2   7 
Gastrointestinal Quality of Life Index (GIQLI) score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 78.2  (27.1)   69.1  (11.9)   73.4  (20.5) 
[1] Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With PEG-J Tube Migration   [ Time Frame: From date of placement up to 4 weeks ]

2.  Secondary:   Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration   [ Time Frame: 4 weeks ]

3.  Secondary:   Patency of Feeding Tube   [ Time Frame: 2 years ]

4.  Secondary:   Technical Success   [ Time Frame: Intra-procedural ]

5.  Secondary:   Intervention Time   [ Time Frame: Intra-procedural ]

6.  Secondary:   Time to Repeat Endoscopy for Tube Replacement   [ Time Frame: 2 years ]

7.  Secondary:   Difficulty of the Procedure   [ Time Frame: Inra-procedural ]

8.  Secondary:   Gastrointestinal Quality of Life Index (GIQLI) Score   [ Time Frame: 3 month ]

9.  Secondary:   Short-term Complications   [ Time Frame: One week ]

10.  Secondary:   Long-term Complications   [ Time Frame: 2 years ]

11.  Secondary:   Direct Cost   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mouen Khashab
Organization: Johns Hopkins Hospital
phone: 443-287-1960
e-mail: mkhasha1@jhmi.edu


Publications:

Responsible Party: Mouen Khashab, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01892267     History of Changes
Other Study ID Numbers: NA_00079056
Study First Received: July 1, 2013
Results First Received: August 19, 2016
Last Updated: April 13, 2017