Diagnostic or Therapeutic LaparoscopyCuldoNCT00848575
A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
An observational study of Diagnostic or Therapeutic Laparoscopy, run by University of Arkansas at 1 site in United States.
Trial summary
The culdoscopic approach will allow for equal or better visualization of female pelvic structures Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diagnostic or Therapeutic Laparoscopy
- What is being tested?
- Flexible Endoscope
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from among women attending the gynecologic clinics or gynecologic oncology clinic of UAMS. Subjects from all races and ethnicities may participate. No children (aged <18 years) are to be enrolled.
Who may be able to join
- Female
- Ages 18 to 70 years old
- Ability to understand and give informed consent
- Scheduled for diagnostic or therapeutic laparoscopy for a clinical indication
- Presence of a uterus and at least one ovary at the initiation of the procedure
Who cannot join
- Documented culdesac mass
- Inability to tolerate anesthesia
- Documentation of positive urine pregnancy test
- History of prior pelvic radiation
- Scheduled for emergency laparoscopy
- Any other medical or psychiatric condition that, in the opinion of the investigative team, will interfere with the ability of the participant to safely complete the study
- History of significant non-compliance with previous therapy or unwillingness to return for follow up visits
- Prior hysterectomy and/or bilateral salpingo-oophorectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
The culdoscopic approach will allow for equal or better visualization of female pelvic structures
- Conditions
- Diagnostic or Therapeutic Laparoscopy
- Being tested
- Flexible Endoscope
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible EndoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Device | The principal Investigator and sub-investigators of this study will identify potential participants that attend the gynecologic oncology or gynecology clinics of UAMS. These subjects will have been scheduled for diagnostic or therapeutic laparoscopy. Based on the Inclusion Criteria and Exclusion Criteria of this study, women who are eligible for the study will be approached to participate. Receives: Device: Flexible Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared.
Measured: 02/2010
Secondary outcomes (1)
Complications related to the procedures will be recorded and, if possible, attributed to one of the two techniques. If feasible, a comparison will be made between complications attributable to each approach.
Measured: 02/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic or Therapeutic LaparoscopyStudies 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
- Observational
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Burnett, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848575
- Sponsor's protocol ID
- 99075
- Acronym
- Culdo
- Status last verified
- Sep 2013
- First submitted
- 19 Feb 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
- ClinicalTrials.gov ID
- NCT00848575
- Acronym / sponsor ID
- Culdo / 99075
- Conditions
- Diagnostic or Therapeutic Laparoscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The culdoscopic approach will allow for equal or better visualization of female pelvic structures
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Device | – | Device: Flexible EndoscopeThe principal Investigator and sub-investigators of this study will identify potential participants that attend the gynecologic oncology or gynecology clinics of UAMS. These subjects will have been scheduled for diagnostic or therapeutic laparoscopy. Based on the Inclusion Criteria and Exclusion Criteria of this study, women who are eligible for the study will be approached to participate. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from among women attending the gynecologic clinics or gynecologic oncology clinic of UAMS. Subjects from all races and ethnicities may participate. No children (aged <18 years) are to be enrolled.
Key inclusion criteria (5 listed)
- Female
- Ages 18 to 70 years old
- Ability to understand and give informed consent
- Scheduled for diagnostic or therapeutic laparoscopy for a clinical indication
- Presence of a uterus and at least one ovary at the initiation of the procedure
Key exclusion criteria (8 listed)
- Documented culdesac mass
- Inability to tolerate anesthesia
- Documentation of positive urine pregnancy test
- History of prior pelvic radiation
- Scheduled for emergency laparoscopy
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 |
|---|---|---|
| Flexible Endoscope | Device | Group 1 - Device |
Primary outcome
Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared.
Time frame: 02/2010
1 secondary outcome
Complications related to the procedures will be recorded and, if possible, attributed to one of the two techniques. If feasible, a comparison will be made between complications attributable to each approach.
Time frame: 02/2010
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
Related trials for Diagnostic or Therapeutic Laparoscopy
RecruitingPhase 1/2
Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingObservational study
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
Gastroesophageal Reflux Disease
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.
Alexander Burnett, MD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic or Therapeutic Laparoscopy, run by University of Arkansas 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Sep 2013. 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?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared. (time frame: 02/2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2013.