NCT01119040

Brief Summary

The purpose of this study is to determine:

  1. 1.Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.
  2. 2.Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.
  3. 3.Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 3, 2012

Completed
Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

May 6, 2010

Results QC Date

October 14, 2010

Last Update Submit

December 12, 2014

Conditions

Malnutrition

Keywords

Dislodged PEG tubeNOTES

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.

    Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.

    30 day follow-up

Study Arms (1)

NOTES PEG Rescue

EXPERIMENTAL

A new way of performing surgery is called Natural Orifice Translumenal Endoscopic Surgery, or NOTES, for short. NOTES may allow surgeons to perform abdominal surgery without any skin incisions. By using natural openings in the body, like the mouth, surgeons can enter the stomach with a tube instead of the traditional method of making an incision in the skin of the abdomen.

Procedure: Natural Orifice Translumenal Endoscopic Surgery

Interventions

Natural Orifice Translumenal Endoscopic SurgeryPROCEDURE

Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery.

Also known as: NOTES
NOTES PEG Rescue

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For retrospective candidates, intra-operative confirmation of dislodged tube as reported in the medical record.
  • The patient must demonstrate pre-operative hemodynamic and respiratory stability
  • No overwhelming medical co-morbidities prohibitive of surgery
  • Subject is 18 years of age or older
  • Subject or subject's legal decision-making proxy agrees to participate, fully understands and signs the informed consent form

You may not qualify if:

  • Esophageal stricture prohibiting passage of an endoscope
  • Any contraindication to surgery
  • Pregnancy or actively breastfeeding women
  • Evidence of active bowel obstruction
  • Synchronous acute abdominal pathology warranting incision-based surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Marks JM, Ponsky JL, Pearl JP, McGee MF. PEG "Rescue": a practical NOTES technique. Surg Endosc. 2007 May;21(5):816-9. doi: 10.1007/s00464-007-9361-2. Epub 2007 Apr 3.

    PMID: 17404790RESULT

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Limitations and Caveats

Study terminated early due to difficulty with patient accrual due to lack of patient population.

Results Point of Contact

Title
Jeffrey Marks, MD/Principal Investigator
Organization
University Hospitals Case Medical Center
jeffrey.marks@UHhospitals.org
216-983-4930

Study Officials

  • Jeffrey Marks, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 7, 2010

Study Start

November 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 5, 2015

Results First Posted

December 3, 2012

Record last verified: 2014-12

Locations

US(1)