Biliary ColicNCT03380572
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
A study testing Senhance Assisted Cholecystectomy and Laparoscopic Cholecystectomy in people with Biliary Colic and Cholecystitis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Biliary Colic, Cholecystitis
- What is being tested?
- Senhance Assisted Cholecystectomy and Laparoscopic Cholecystectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
Who cannot join
- Patients unable tor unwilling to consent BMI >40
Trial locations and contacts
1 site in 1 country.
About this study
The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.
Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.
- Conditions
- Biliary Colic, Cholecystitis
- Being tested
- Senhance Assisted Cholecystectomy, Laparoscopic Cholecystectomy
- Keywords
- Robotic Surgery
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senhance Assisted CholecystectomyDevice
Cholecystectomy performed using Senhance surgical robotic system
Laparoscopic CholecystectomyProcedure or surgery
Standard laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Senhance Cholecystectomy | Experimental | Cholecystectomy operation performed using Senhance robotic system Receives: Device: Senhance Assisted Cholecystectomy |
| Laparoscopic Cholecystectomy | Active comparator | Cholecystectomy operation performed using standard laparoscopic instruments Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Measured: 1 day
Secondary outcomes (1)
Morbidity Data
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start10 Feb 2017
- Primary completion1 Dec 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Biliary ColicStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravi Aggarwal, Imperial College London
- Investigators
- Sanjay Purkayastha, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380572
- Sponsor's protocol ID
- SenhanceChole
- Status last verified
- May 2019
- First submitted
- 11 Dec 2017
- Last updated
- 21 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
- ClinicalTrials.gov ID
- NCT03380572
- Acronym / sponsor ID
- SenhanceChole
- Conditions
- Biliary Colic, Cholecystitis
- Keywords
- Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.
Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senhance Cholecystectomy | Experimental | Device: Senhance Assisted CholecystectomyCholecystectomy operation performed using Senhance robotic system |
| Laparoscopic Cholecystectomy | Active comparator | Procedure: Laparoscopic CholecystectomyCholecystectomy operation performed using standard laparoscopic instruments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
Key exclusion criteria (1 listed)
- Patients unable tor unwilling to consent BMI >40
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 |
|---|---|---|
| Senhance Assisted CholecystectomyCholecystectomy performed using Senhance surgical robotic system | Device | Senhance Cholecystectomy |
| Laparoscopic CholecystectomyStandard laparoscopic cholecystectomy | Procedure or surgery | Laparoscopic Cholecystectomy |
Primary outcome
Operative Time
Time frame: 1 day
1 secondary outcome
Morbidity Data
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sanjay Purkayastha, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senhance Assisted Cholecystectomy and Laparoscopic Cholecystectomy in people with Biliary Colic and Cholecystitis, run by Imperial College London at 1 site in United Kingdom.
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 1 inclusion and 1 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 21 May 2019. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Operative Time (time frame: 1 day). 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 21 May 2019; AzTrials last refreshed its copy on 27 Oct 2026.