CholelithiasisNCT00711581
Evaluation of Laparoscopic Internal Retractor Device
A study testing Gallbladder retraction in people with Cholelithiasis, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Gallbladder retraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2008to Aug 2011
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic cholelithiasis
- Age 18-60
- ASA 1-2
- Able to sign an informed consent
Who cannot join
- ASA 3 or more
- Acute cholecystitis
- Choledocholithiasis
- Coagulation disorders
- Patients on blood thinners
- Use of Steroids
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Yoav Mintz
Jerusalem, 91120
Hadassah Medical Organization
Jerusalem
About this study
Official title: Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device
The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.
- Conditions
- Cholelithiasis
- Being tested
- Gallbladder retraction
- Keywords
- Cholecystectomy, Cholecystectomy, Laparoscopic, Laparoscopy
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallbladder retractionDevice
Also called Endograb
The gallbladder will be retracted using the Endograb retractor
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor. Receives: Device: Gallbladder retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome will be either "success" or "failure". Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument.
Measured: 1 year
Secondary outcomes (1)
No adverse effects related directly to the use of the Endograb retractor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoav Mintz, MD, Principal investigator, Hadassah Medical OrganizationRam Elazary, MD, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711581
- Sponsor's protocol ID
- Endograb-HMO-CTIL
- Status last verified
- Jun 2008
- First submitted
- 8 Jul 2008
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device
- ClinicalTrials.gov ID
- NCT00711581
- Acronym / sponsor ID
- Endograb-HMO-CTIL
- Conditions
- Cholelithiasis
- Keywords
- Cholecystectomy, Cholecystectomy, Laparoscopic, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Jul 2008 (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 purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Gallbladder retractionSubjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptomatic cholelithiasis
- Age 18-60
- ASA 1-2
- Able to sign an informed consent
Key exclusion criteria (6 listed)
- ASA 3 or more
- Acute cholecystitis
- Choledocholithiasis
- Coagulation disorders
- Patients on blood thinners
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 |
|---|---|---|
| Gallbladder retractionAlso: EndograbThe gallbladder will be retracted using the Endograb retractor | Device | A |
Primary outcome
Outcome will be either "success" or "failure". Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument.
Time frame: 1 year
1 secondary outcome
No adverse effects related directly to the use of the Endograb retractor.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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.
Yoav Mintz, MD principal investigator
Hadassah Medical Organization
Ram Elazary, MD study director
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gallbladder retraction in people with Cholelithiasis, run by Hadassah Medical Organization at 2 sites in Israel.
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 6 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 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Outcome will be either "success" or "failure". Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument. (time frame: 1 year). 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 10 Apr 2014.