CholelithiasisIRB#08-181NCT01146184
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
A study testing Flexible endoscope and Ethicon Manually Articulating Device in people with Cholelithiasis and Pain, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a flexible endoscope passed through a single umbilical skin incision, as previously reported, now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the endoscope. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholelithiasis, Pain
- What is being tested?
- Flexible endoscope and Ethicon Manually Articulating Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncomplicated Biliary Colic
- ASA I or II
Who cannot join
- Pregnant Women
- Children
- Institutionalized mentally disabled
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a flexible endoscope passed through a single umbilical skin incision, as previously reported, now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the endoscope.
Read the detailed description
Single incision laparoscopic surgeries (SILS) have taken a step further the field of minimally invasive surgery with reports of a variety of laparoscopic procedures performed through a single incision.
However the technique is challenging due to the proximity of the instruments passed through the single umbilical skin incision. Several improvisions were made to accommodate this technical restriction by making flexible umbilical ports that accommodate several trocars, or usage of different length instruments to strategically place the surgeons, minimizing collision and improving ergonomics.
The flexibility of the endoscope will allow improved freedom of movement within the abdominal cavity and ease of gallbladder dissection. The investigators believe that this technique will take advantage of the flexible nature of the endoscope while avoiding the risks of transluminal surgery inherent in natural orifice surgery. Flexible endoscope offers an excellent solution to SILS, with its flexible optics and ability to pass working instruments through it.
The flexible endoscope to be used ia a 12mm dual channel Karl Storz or Olympus gastroscope.Ethicon instruments are essentially like traditional endoscopic instruments with an extra joint at the working end, mimicking a wrist joint. These instruments are FDA listed/cleared pursuant to 510(k) provisions of the Food, Drug and Cosmetic Act with general indications for use in endoscopic or laparoscopic procedures. We will be using an articulating grasper, articulating biopsy forcepts, and an articulating needle knife.
We will measure pain with pain scales.
- Conditions
- Cholelithiasis, Pain
- Being tested
- Flexible endoscope and Ethicon Manually Articulating Device
- Keywords
- Cholelithiasis, Single Incision, Flexible Endoscope, Ethicon Manually Articulating Device, Pain
- Medical subject headings
- Cholelithiasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible endoscope and Ethicon Manually Articulating DeviceDevice
Also called Single Incision cholecystectomy using flexible endoscope, Ethicon instruments
Using the Flexible Endoscope and the Ethicon Manually Articulating Device, removal of the gallbladder through a single incision is improved.
| Study group | Role | What they receive |
|---|---|---|
| Single-Incision Cholecystectomy | Experimental | Extracting the gallbladder laparoscopically is made difficult through a single incision. Receives: Device: Flexible endoscope and Ethicon Manually Articulating Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device
Using flexible endoscopes and the Ethicon Manually Articulating Device will facilitate the procedure of removing the gallbladder by allowing more flexibility and greater movement in the abdominal cavity, better triangulation for dissection and increased quality of optics for the single-incision technique.
Measured: Intra-Operative
Secondary outcomes (2)
Post-operative Pain
Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.
Measured: 1 month
Complications
Measure intra-operative and post-operative complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: the manufacturer never released the instruments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Sponsor
- Investigators
- Julio Teixeira, MD, Principal investigator, St Luke's Roosevelt Hospital Center- Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146184
- Sponsor's protocol ID
- 08-181
- Acronym
- IRB#08-181
- Status last verified
- Aug 2015
- First submitted
- 1 Jun 2010
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ng WT, Kong CK, Wong YT. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 Nov;84(11):1627. No abstract available.
PubMed 9393287Teixeira J, McGill K, Koshy N, McGinty J, Todd G. Laparoscopic single-site surgery for placement of adjustable gastric band--a series of 22 cases. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):41-5. doi: 10.1016/j.soard.2009.03.220. Epub 2009 Apr 16.
PubMed 19560980Petersen LR, Doll LS. Human immunodeficiency virus type 1-infected blood donors: epidemiologic, laboratory, and donation characteristics. The HIV Blood Donor Study Group. Transfusion. 1991 Oct;31(8):698-703. doi: 10.1046/j.1537-2995.1991.31892023493.x.
PubMed 1926312Slim K, Pezet D, Stencl J Jr, Lechner C, Le Roux S, Lointier P, Chipponi J. Laparoscopic cholecystectomy: an original three-trocar technique. World J Surg. 1995 May-Jun;19(3):394-7. doi: 10.1007/BF00299168.
PubMed 7638995
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
- ClinicalTrials.gov ID
- NCT01146184
- Acronym / sponsor ID
- IRB#08-181 / 08-181
- Conditions
- Cholelithiasis, Pain
- Keywords
- Cholelithiasis, Single Incision, Flexible Endoscope, Ethicon Manually Articulating Device, Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the manufacturer never released the instruments
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Nov 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Jun 2010 (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 aim of this study is to improve the technique of laparoscopic cholecystectomy by using a flexible endoscope passed through a single umbilical skin incision, as previously reported, now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the endoscope.
Detailed description
Single incision laparoscopic surgeries (SILS) have taken a step further the field of minimally invasive surgery with reports of a variety of laparoscopic procedures performed through a single incision.
However the technique is challenging due to the proximity of the instruments passed through the single umbilical skin incision. Several improvisions were made to accommodate this technical restriction by making flexible umbilical ports that accommodate several trocars, or usage of different length instruments to strategically place the surgeons, minimizing collision and improving ergonomics.
The flexibility of the endoscope will allow improved freedom of movement within the abdominal cavity and ease of gallbladder dissection. The investigators believe that this technique will take advantage of the flexible nature of the endoscope while avoiding the risks of transluminal surgery inherent in natural orifice surgery. Flexible endoscope offers an excellent solution to SILS, with its flexible optics and ability to pass working instruments through it.
The flexible endoscope to be used ia a 12mm dual channel Karl Storz or Olympus gastroscope.Ethicon instruments are essentially like traditional endoscopic instruments with an extra joint at the working end, mimicking a wrist joint. These instruments are FDA listed/cleared pursuant to 510(k) provisions of the Food, Drug and Cosmetic Act with general indications for use in endoscopic or laparoscopic procedures. We will be using an articulating grasper, articulating biopsy forcepts, and an articulating needle knife.
We will measure pain with pain scales.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Incision Cholecystectomy | Experimental | Device: Flexible endoscope and Ethicon Manually Articulating DeviceExtracting the gallbladder laparoscopically is made difficult through a single incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Uncomplicated Biliary Colic
- ASA I or II
Key exclusion criteria (4 listed)
- Pregnant Women
- Children
- Institutionalized mentally disabled
- Prisoners
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 and Ethicon Manually Articulating DeviceAlso: Single Incision cholecystectomy using flexible endoscope, Ethicon instrumentsUsing the Flexible Endoscope and the Ethicon Manually Articulating Device, removal of the gallbladder through a single incision is improved. | Device | Single-Incision Cholecystectomy |
Primary outcome
Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device
Time frame: Intra-Operative
Using flexible endoscopes and the Ethicon Manually Articulating Device will facilitate the procedure of removing the gallbladder by allowing more flexibility and greater movement in the abdominal cavity, better triangulation for dissection and increased quality of optics for the single-incision technique.
2 secondary outcomes
Post-operative Pain
Time frame: 1 month
Complications
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Background: PubMed 9393287Ng WT, Kong CK, Wong YT. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 Nov;84(11):1627. No abstract available.
- Background: PubMed 19560980Teixeira J, McGill K, Koshy N, McGinty J, Todd G. Laparoscopic single-site surgery for placement of adjustable gastric band--a series of 22 cases. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):41-5. doi: 10.1016/j.soard.2009.03.220. Epub 2009 Apr 16.
- Background: PubMed 1926312Petersen LR, Doll LS. Human immunodeficiency virus type 1-infected blood donors: epidemiologic, laboratory, and donation characteristics. The HIV Blood Donor Study Group. Transfusion. 1991 Oct;31(8):698-703. doi: 10.1046/j.1537-2995.1991.31892023493.x.
- Background: PubMed 7638995Slim K, Pezet D, Stencl J Jr, Lechner C, Le Roux S, Lointier P, Chipponi J. Laparoscopic cholecystectomy: an original three-trocar technique. World J Surg. 1995 May-Jun;19(3):394-7. doi: 10.1007/BF00299168.
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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.
Julio Teixeira, MD principal investigator
St Luke's Roosevelt Hospital Center- Surgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible endoscope and Ethicon Manually Articulating Device in people with Cholelithiasis and Pain, run by St. Luke's-Roosevelt Hospital Center 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 2 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: withdrawn, as of the sponsor's last update on 7 Mar 2016. 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 withdrawn before enrolling participants, so there are no results.
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?
Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device (time frame: Intra-Operative). 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 NCT01146184, which also lists 4 linked publications.
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 7 Mar 2016; AzTrials last refreshed its copy on 3 Nov 2026.