Trial Outcomes & Findings for Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue" (NCT NCT01119040)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

30 day follow-up

Results posted on

2015-01-05

Participant Flow

Patients were recruited at University Hospitals Case medical Center between November 2007 and July 2010.

Participant milestones

Participant milestones
Measure	NOTES "PEG Rescue" 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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peg Rescue n=1 Participants Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
Age, Customized Over the age of 18 yrs	1 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants
number of days to assure leak-proof gastrocutaneous tract	1 Days n=93 Participants

PRIMARY outcome

Timeframe: 30 day follow-up

Population: Only 1 subject due to low accrual

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

Outcome measures

Outcome measures
Measure	NOTES PEG Rescue n=1 Participants 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.
Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.	1 participants

Adverse Events

NOTES PEG Rescue

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Marks, MD/Principal Investigator

University Hospitals Case Medical Center

Phone: 216-983-4930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place