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NCT00541593 · ClinicalTrials.gov registry record · NA

Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts

A NA study, sponsored by Baystate Medical Center.

Terminated
Registry status
NA
Development phase
5
Enrollment target

NCT00541593: Clinical Trial NA study, sponsored by Baystate Medical Center.

NCT00541593 is a NA study that was terminated before completion, run by Baystate Medical Center. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00541593, a NA study, was terminated before completion, sponsored by Baystate Medical Center.

TERMINATED
Registry status
NA
Development phase
5 participants
Enrollment target

Study Summary

Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions. Pancreatic pseudocysts are cavities that form typically in the lesser sac following an episode of acute pancreatitis, that may be able to be drained by a variety of techniques, including endoscopically. Chronic pseudocysts often require surgical drainage into the stomach. The medical device company known as "Power Medical Interventions" has a computer-powered surgical stapler which rests on a flexible shaft. Following the insertion of the endoscope, the powered stapler will be passed alongside the endoscope to help the surgeon and gastroenterologist (working as a team) to see where to properly place the stapler. Once the stapler is in position, one jaw of the stapler will be placed into the pseudocyst, and the other jaw will be left in the stomach. The stapler will then be closed and fired, creating a permanent connection between the two hollow spaces and allow the contents of the pseudocyst to drain naturally out into the stomach and intestines. Utilizing this technique, a surgical incision is avoided. Hypothesis: Patients who undergo the Natural Orifice Translumenal Endoscopic Surgery for treatment of their pancreatic pseudocyst will experience effective treatment with less discomfort and with quicker recovery than standard surgical techniques.

Primary Outcome

Number of patients who died as a result of the surgery: Death (mortality). Please note that pain was previously listed as an outcome measure, but this was edited out of this submission and was not tracked as an outcome measure.

Interventions

  • PROCEDURE Pancreatic Pseudocystgastrostomy

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2007-09
Est. Completion 2011-06
Phase NA
Baystate Medical Center

36 total trials

Why NCT00541593 stopped before completion

NCT00541593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Pancreatic Pseudocystgastrostomy is the first listed.

NCT00541593 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00541593 about?

NCT00541593 is a clinical study titled "Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts". Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multidisciplinary teams consist...

What is the current status of trial NCT00541593?

This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2007-09. Estimated completion is 2011-06.

What interventions are being tested in trial NCT00541593?

The interventions under investigation include: Pancreatic Pseudocystgastrostomy (PROCEDURE).

Who is sponsoring clinical trial NCT00541593?

This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00541593's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00541593, the US trial registry maintained by the National Library of Medicine. NCT00541593 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.