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Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance (NOTES)

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ClinicalTrials.gov Identifier: NCT00962650
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Abdominal Adhesions
Intervention Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance
Enrollment 7
Recruitment Details Study Initiation Date: 09 June 2009 (First Informed consent signed) Study Completion Date:03 May 2010 (Last subject last visit) Enrollment Location: The Ohio State University Medical Center
Pre-assignment Details All enrolled subjects provided informed consent to participate in the study, met protocol entry criteria, and had the study procedure attempted (ITT population).
Arm/Group Title Natural Orifice Transgastric Diagnostic Peritineoscopy
Hide Arm/Group Description Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
Period Title: Overall Study
Started 10
Completed 8
Not Completed 2
Reason Not Completed
Transgastric DP was not completed             2
Arm/Group Title Natural Orifice Transgastric Diagnostic Peritineoscopy
Hide Arm/Group Description Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  90.0%
>=65 years
1
  10.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
54.2  (9.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
9
  90.0%
Male
1
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Completion of Diagnostic Peritineoscopy
Hide Description

Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox

Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome.

Time Frame Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The subject pool was limited to individuals scheduled for Rouen Y gastric bypass(Intent to Treat population). There was no statistical analysis. Success was based on completion of the diagnostic peritineoscopy procedure after transgastric access.
Arm/Group Title Natural Orifice Transgastric Diagnostic Peritineoscopy
Hide Arm/Group Description:
Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
8
Time Frame Adverse events were collected from Study Initiation Date (first Informed Consent signed) 09 June 2009 until Study Completion Date (last participant's last visit) on 03 May 2010.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Natural Orifice Transgastric Diagnostic Peritineoscopy
Hide Arm/Group Description Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
All-Cause Mortality
Natural Orifice Transgastric Diagnostic Peritineoscopy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Natural Orifice Transgastric Diagnostic Peritineoscopy
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Surgical and medical procedures   
ESOPHAGEAL INJURY/ OESOPHAGEAL INJURY 1 [1]  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA 5.2
[1]
ESOPHAGEAL INJURY/ OESOPHAGEAL INJURY occurred when passing study device down esophagus.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Natural Orifice Transgastric Diagnostic Peritineoscopy
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Ten male and female subjects indicated for Diagnostic Peritoneoscopy in advance of Roux-en Y Gastic Bypass procedure, who had a history of previous abdominal surgery, and met study Inclusion Criteria, were enrolled in the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Schwiers, Principal Biostatistician
Organization: Ethicon Endo-Surgery, Inc.
Phone: 513-337-1172
Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00962650     History of Changes
Other Study ID Numbers: CI-08-0007
First Submitted: August 12, 2009
First Posted: August 20, 2009
Results First Submitted: December 20, 2010
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012