Abdominal AdhesionsNOTESNCT00962650

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

A study testing Transgastric diagnostic peritoneoscopy with laparoscopic assistance in people with Abdominal Adhesions, run by Ethicon Endo-Surgery at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Adhesions
What is being tested?: Transgastric diagnostic peritoneoscopy with laparoscopic assistance
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Oct 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

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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).

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.

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

Conditions: Abdominal Adhesions
Being tested: Transgastric diagnostic peritoneoscopy with laparoscopic assistance
Keywords: abdominal adhesions, diagnostic peritoneoscopy, Natural Orifice Transluminal Endoscopic Surgery, NOTES

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transgastric diagnostic peritoneoscopy with laparoscopic assistanceDevice
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)

Study groups in NCT00962650
Study group	Role	What they receive
NOTES Toolbox	Experimental	Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial Receives: Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Oct 2010

First posted20 Aug 2009 (estimated)
Study startJun 2009
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Abdominal AdhesionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00962650
Sponsor's protocol ID: CI-08-0007
Acronym: NOTES
Status last verified: Mar 2012
First submitted: 12 Aug 2009
Last updated: 29 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Abdominal Adhesions trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.
ClinicalTrials.gov ID: NCT00962650
Acronym / sponsor ID: NOTES / CI-08-0007
Conditions: Abdominal Adhesions
Keywords: abdominal adhesions, diagnostic peritoneoscopy, Natural Orifice Transluminal Endoscopic Surgery, NOTES
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 20 Aug 2009 (estimated)
Results: Posted 29 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NOTES Toolbox	Experimental	Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistanceMultiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transgastric diagnostic peritoneoscopy with laparoscopic assistanceDevice: 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)	Device	NOTES Toolbox

Primary outcome

Completion of Diagnostic Peritineoscopy
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
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.

Results and safety

Results posted to the registry on 29 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Natural Orifice Transgastric Diagnostic Peritineoscopy	10	8

Primary outcome: Completion of Diagnostic Peritineoscopy

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. Number. Unit: Participants

Measure	Natural Orifice Transgastric Diagnostic Peritineoscopy n = 10
Value	8

Population analysed: 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.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Natural Orifice Transgastric Diagnostic Peritineoscopy	1 of 10 (10%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction
Adhesive Small Bowel Obstruction
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey W Hazey, MD, FACS principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transgastric diagnostic peritoneoscopy with laparoscopic assistance in people with Abdominal Adhesions, run by Ethicon Endo-Surgery at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of Diagnostic Peritineoscopy (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00962650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2012.