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

Primary Purpose

Abdominal Adhesions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transgastric diagnostic peritoneoscopy with laparoscopic assistance
Sponsored by
Ethicon Endo-Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Adhesions focused on measuring abdominal adhesions, diagnostic peritoneoscopy, Natural Orifice Transluminal Endoscopic Surgery, NOTES

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women will be enrolled in this study who:

  • Are willing to give consent and comply with evaluation and treatment schedule;
  • At least 18 years of age;
  • Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site;
  • Have a history of open abdominal surgery or laparoscopic abdominal surgery;
  • ASA Classification I, II, or III (Appendix II); and
  • Have a negative serum pregnancy test (for women of childbearing potential).

Exclusion Criteria:

Subjects will be excluded from the study for any of the following:

  • Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
  • Acute cholecystitis or acute pancreatitis;
  • Evidence of abdominal abscess or mass;
  • Diffuse peritonitis;
  • Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
  • Clinical diagnosis of sepsis;
  • Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
  • Planned concurrent surgical procedure other than RYGB or adhesiolysis;
  • Prior or planned major surgical procedure within 30 days before or after study procedure;
  • Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
  • Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or
  • Any condition which precludes compliance with the study (Investigator discretion).

Sites / Locations

  • The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NOTES Toolbox

Arm Description

Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial

Outcomes

Primary Outcome Measures

Completion of Diagnostic Peritineoscopy
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.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2009
Last Updated
March 1, 2012
Sponsor
Ethicon Endo-Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT00962650
Brief Title
Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance
Acronym
NOTES
Official Title
A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon Endo-Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Adhesions
Keywords
abdominal adhesions, diagnostic peritoneoscopy, Natural Orifice Transluminal Endoscopic Surgery, NOTES

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NOTES Toolbox
Arm Type
Experimental
Arm Description
Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial
Intervention Type
Device
Intervention Name(s)
Transgastric diagnostic peritoneoscopy with laparoscopic assistance
Intervention Description
Device: Natural Orifice Transgastric Endoscopic (NOTES GEN 1 Toolbox): Articulating Hook Knife(IN2505), Articulating Snare (IN2503), Articulating Needle Knife(IN2504), Articulating Graspers(IN2501 or IN2506), Articulating Biopsy Forceps(IN2502), Steerable Flexible Trocar (IN0501) with Rotary Access Needle (IN0502), Flexible Bipolar Hemostasis Forceps (IN0301), and/or Flexible Maryland Dissector(IN1601)
Primary Outcome Measure Information:
Title
Completion of Diagnostic Peritineoscopy
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women will be enrolled in this study who: Are willing to give consent and comply with evaluation and treatment schedule; At least 18 years of age; Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site; Have a history of open abdominal surgery or laparoscopic abdominal surgery; ASA Classification I, II, or III (Appendix II); and Have a negative serum pregnancy test (for women of childbearing potential). Exclusion Criteria: Subjects will be excluded from the study for any of the following: Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable); Acute cholecystitis or acute pancreatitis; Evidence of abdominal abscess or mass; Diffuse peritonitis; Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy; Clinical diagnosis of sepsis; Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial; Planned concurrent surgical procedure other than RYGB or adhesiolysis; Prior or planned major surgical procedure within 30 days before or after study procedure; Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints; Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or Any condition which precludes compliance with the study (Investigator discretion).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey W Hazey, MD, FACS
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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

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