Tissue Retraction SystemTRSNCT03553199
Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System
A study testing TRS, Tissue Retraction System in people with Tissue Retraction System, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Endoscopic submucosal dissection (ESD) is an endoscopic technique that allows the removal of lesions of the gastrointestinal tract. The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that cannot be removed enbloc with standard polypectomy or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tissue Retraction System
- What is being tested?
- TRS, Tissue Retraction System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2018to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left colon and rectal lesions matching the criteria of ESD removal: depressed/flat elevated morphology and irregular or nongranular surface pattern, larger than 20 mm; lesions that cannot be optimally and radically removed with standard polypectomy or EMR
- age ≥18 years
- ability to sign the informed consent
Who cannot join
- deep submucosal invasion diagnosed by distorted pit (Kudo's type V) and/or capillary (Sano's type III) patterns [5];
- poor general condition (American Society of Anesthesiologists score ≥ 3);
- coagulation disorders;
- pregnancy and breastfeeding;
- inability to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System
Endoscopic submucosal dissection (ESD) is an endoscopic technique that allows the removal of lesions of the gastrointestinal tract. The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that cannot be removed enbloc with standard polypectomy or endoscopic mucosal resection (EMR) and for lesions that are > 20 mm in diameter, with a high probability of having a limited submucosal invasion.
ESD is a technically difficult and time-consuming procedure that is very difficult to learn and to perform, but it allows higher enbloc resection rates compared to other endoscopic techniques and is less invasive than surgery requiring less length of hospital stay.
Recently, several new techniques and devices have been developed to facilitate ESD and to overcome difficulties related to challenging situations. The main difficulties are related to the instability of the operating field, due to the physiologic peristalsis, and to the loss of traction, due to the single operating channel.
Read the detailed description
Tissue Retraction System (TRS, Boston scientific) is a new endoscopic platform, that consists of an expandable and dynamically-controlled intra-luminal chamber, mounted on a flexible overtube, and two associated specifically designed retractor graspers. The system is front-loaded over the colonoscope and introduced into the colon. When the target area is reached, the retractor system is deployed creating an expanded, optimally reconfigured and stable operating field around the target lesion. Then endoscopic removal of the lesion is performed using available endoscopic instruments (injection needles, knives, snares, etc) through the operating channel of the colonoscope with assistance of two retractor graspers. Each accessory within the TRS can be moved forward and backward, left or right, rotated 360 degrees, and can be advanced out and pulled in, regardless of the TRS.
The investigators hypothesize that the TRS can improve visualization of lesions and stabilize the work environment by allowing retraction and tissue resection during ESD.
TRS is a new device not yet commercially available, thus no study has been already performed in humans to evaluate its feasibility and safety to speed up the ESD of left colon and rectum lesions.
The investigator's proposal is to perform a pilot study to evaluate the feasibility, the efficacy and the safety in patients undergoing ESD of colorectal lesions with the assistance of the TRS.
- Conditions
- Tissue Retraction System
- Being tested
- TRS, Tissue Retraction System
- Keywords
- Tissue Retraction System, Colorectal polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRS, Tissue Retraction SystemDevice
Tissue Retraction System
| Study group | Role | What they receive |
|---|---|---|
| TRS | Experimental | TRS, Tissue resection system Receives: Device: TRS, Tissue Retraction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is the feasibility, defined as the technical success rate, to perform an enbloc ESD with the assistance of the TRS.
Measured: 9 months
Secondary outcomes (1)
Secondary endpoints are: the efficacy, defined as the rate of lesions removed enbloc and the rate of curative ESD (with an R0 resection); the safety, defined as the rate of adverse events (AEs).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start28 May 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue Retraction SystemStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553199
- Sponsor's protocol ID
- TRS
- Acronym
- TRS
- Status last verified
- Mar 2021
- First submitted
- 29 May 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System
- ClinicalTrials.gov ID
- NCT03553199
- Acronym / sponsor ID
- TRS / TRS
- Conditions
- Tissue Retraction System
- Keywords
- Tissue Retraction System, Colorectal polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- 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.
Endoscopic submucosal dissection (ESD) is an endoscopic technique that allows the removal of lesions of the gastrointestinal tract. The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that cannot be removed enbloc with standard polypectomy or endoscopic mucosal resection (EMR) and for lesions that are > 20 mm in diameter, with a high probability of having a limited submucosal invasion.
ESD is a technically difficult and time-consuming procedure that is very difficult to learn and to perform, but it allows higher enbloc resection rates compared to other endoscopic techniques and is less invasive than surgery requiring less length of hospital stay.
Recently, several new techniques and devices have been developed to facilitate ESD and to overcome difficulties related to challenging situations. The main difficulties are related to the instability of the operating field, due to the physiologic peristalsis, and to the loss of traction, due to the single operating channel.
Detailed description
Tissue Retraction System (TRS, Boston scientific) is a new endoscopic platform, that consists of an expandable and dynamically-controlled intra-luminal chamber, mounted on a flexible overtube, and two associated specifically designed retractor graspers. The system is front-loaded over the colonoscope and introduced into the colon. When the target area is reached, the retractor system is deployed creating an expanded, optimally reconfigured and stable operating field around the target lesion. Then endoscopic removal of the lesion is performed using available endoscopic instruments (injection needles, knives, snares, etc) through the operating channel of the colonoscope with assistance of two retractor graspers. Each accessory within the TRS can be moved forward and backward, left or right, rotated 360 degrees, and can be advanced out and pulled in, regardless of the TRS.
The investigators hypothesize that the TRS can improve visualization of lesions and stabilize the work environment by allowing retraction and tissue resection during ESD.
TRS is a new device not yet commercially available, thus no study has been already performed in humans to evaluate its feasibility and safety to speed up the ESD of left colon and rectum lesions.
The investigator's proposal is to perform a pilot study to evaluate the feasibility, the efficacy and the safety in patients undergoing ESD of colorectal lesions with the assistance of the TRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRS | Experimental | Device: TRS, Tissue Retraction SystemTRS, Tissue resection system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- left colon and rectal lesions matching the criteria of ESD removal: depressed/flat elevated morphology and irregular or nongranular surface pattern, larger than 20 mm; lesions that cannot be optimally and radically removed with standard polypectomy or EMR
- age ≥18 years
- ability to sign the informed consent
Key exclusion criteria (5 listed)
- deep submucosal invasion diagnosed by distorted pit (Kudo's type V) and/or capillary (Sano's type III) patterns [5];
- poor general condition (American Society of Anesthesiologists score ≥ 3);
- coagulation disorders;
- pregnancy and breastfeeding;
- inability to sign the informed consent.
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 |
|---|---|---|
| TRS, Tissue Retraction SystemTissue Retraction System | Device | TRS |
Primary outcome
Primary endpoint is the feasibility, defined as the technical success rate, to perform an enbloc ESD with the assistance of the TRS.
Time frame: 9 months
1 secondary outcome
Secondary endpoints are: the efficacy, defined as the rate of lesions removed enbloc and the rate of curative ESD (with an R0 resection); the safety, defined as the rate of adverse events (AEs).
Time frame: 12 months
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 18 Mar 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRS, Tissue Retraction System in people with Tissue Retraction System, run by Istituto Clinico Humanitas at 1 site in Italy.
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 3 inclusion and 5 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 18 Mar 2021. 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 Italy. 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?
Primary endpoint is the feasibility, defined as the technical success rate, to perform an enbloc ESD with the assistance of the TRS. (time frame: 9 months). 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 18 Mar 2021.