CholecystectomyNCT02163239
Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield
An observational study of Cholecystectomy and Benign Hysterectomy, run by Minimally Invasive Devices, Inc. at 1 site in United States.
Trial summary
This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy
- What is being tested?
- Cannula and Blunt Obturator
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from a population of patients who are from the medical practice of the study investigator and who are scheduled to undergo robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy
Who may be able to join
- Male or female, 18 years or older
- Scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator
- Suitable candidate for surgery
- Is able to read and understand the informed consent form and has voluntarily provided written informed consent
Who cannot join
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- Subjects with known allergy (hypersensitivity) to Docusate Sodium
- Use of Surgiquest AirSeal during the laparoscopic single-site surgery
- Use of humidified insufflation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Market Study: Use of the Reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator and the Robotic FloShield System During Robot-assisted Laparoscopic Single-Site Surgery. A Multicenter Historical Control Comparison
This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site laparoscopic surgery.
- Conditions
- Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy
- Being tested
- Cannula and Blunt Obturator
- Keywords
- FloShield, MID, Minimally invasive surgery, Minimally Invasive devices, Robot-assisted Laparoscopic Surgery, Single-site Laparoscopic Surgery, Single Incision Laparoscopic Surgery, Cannula, Blunt Obturator, Cholecystectomy, Benign hysterectomy, Salpingo-oophorectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannula and Blunt ObturatorDevice
Also called FloShield 10mm Endoscopic Cannula, FRT10C, FloShield Blunt Oburator, FRT10B
The FloShield 10mm Endoscopic Cannula and Blunt Obturator will be used to maintain access to the peritoneal cavity during robot-assisted single site laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| 10mm Cannula | Subjects that are scheduled for a robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator Receives: Device: Cannula and Blunt Obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate
Completion rate is the percentage of users who successfully complete the task without critical errors. A critical error is defined as an error that results in an incorrect or incomplete outcome (Grade 1 and 2). In other words, the completion rate represents the percentage of participants who, when they are finished with the specified task, have an "output" that is correct (Grade 3 - 5). Note: If a participant requires assistance in order to achieve a correct output then the task will be scored as a critical error and the overall completion rate for the task will be affected. A completion rate of 90% is the goal for each task in this usability test.
Measured: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)
Secondary outcomes (1)
Performance
The secondary outcome from the study will be an assessment of the performance of the FloShield 10mm Cannula and Oburator/FloShield System in its ability to defog and clean the laparoscopic lens.
Measured: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Not meeting primary objective of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minimally Invasive Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wayne Poll, MD, Study director, Minimally Invasive Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163239
- Sponsor's protocol ID
- FRT-0001
- Status last verified
- Sep 2015
- First submitted
- 10 Jun 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Study: Use of the Reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator and the Robotic FloShield System During Robot-assisted Laparoscopic Single-Site Surgery. A Multicenter Historical Control Comparison
- ClinicalTrials.gov ID
- NCT02163239
- Acronym / sponsor ID
- FRT-0001
- Conditions
- Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy
- Keywords
- FloShield, MID, Minimally invasive surgery, Minimally Invasive devices, Robot-assisted Laparoscopic Surgery, Single-site Laparoscopic Surgery, Single Incision Laparoscopic Surgery, Cannula
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not meeting primary objective of the study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minimally Invasive Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Jun 2014 (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.
This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site laparoscopic surgery.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10mm Cannula | – | Device: Cannula and Blunt ObturatorSubjects that are scheduled for a robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from a population of patients who are from the medical practice of the study investigator and who are scheduled to undergo robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy
Key inclusion criteria (4 listed)
- Male or female, 18 years or older
- Scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator
- Suitable candidate for surgery
- Is able to read and understand the informed consent form and has voluntarily provided written informed consent
Key exclusion criteria (4 listed)
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- Subjects with known allergy (hypersensitivity) to Docusate Sodium
- Use of Surgiquest AirSeal during the laparoscopic single-site surgery
- Use of humidified insufflation
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 |
|---|---|---|
| Cannula and Blunt ObturatorAlso: FloShield 10mm Endoscopic Cannula, FRT10C, FloShield Blunt Oburator, FRT10BThe FloShield 10mm Endoscopic Cannula and Blunt Obturator will be used to maintain access to the peritoneal cavity during robot-assisted single site laparoscopic surgery | Device | 10mm Cannula |
Primary outcome
Completion rate
Time frame: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)
Completion rate is the percentage of users who successfully complete the task without critical errors. A critical error is defined as an error that results in an incorrect or incomplete outcome (Grade 1 and 2). In other words, the completion rate represents the percentage of participants who, when they are finished with the specified task, have an "output" that is correct (Grade 3 - 5). Note: If a participant requires assistance in order to achieve a correct output then the task will be scored as a critical error and the overall completion rate for the task will be affected. A completion rate of 90% is the goal for each task in this usability test.
1 secondary outcome
Performance
Time frame: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)
Results and safety
The study was stopped early (reason given: Not meeting primary objective of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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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.
Wayne Poll, MD study director
Minimally Invasive Devices
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 Cholecystectomy and Benign Hysterectomy, run by Minimally Invasive Devices, Inc. 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 4 inclusion and 4 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 28 Sep 2015. 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: Not meeting primary objective of the study). 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?
Completion rate (time frame: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)). 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 28 Sep 2015; AzTrials last refreshed its copy on 31 Oct 2026.