Stomach NeoplasmNCT01910974
Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System
A study testing endoscopic sub-mucosal dissection in people with Stomach Neoplasm and Intestinal Neoplasm, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stomach Neoplasm, Intestinal Neoplasm, Rectal Neoplasm
- What is being tested?
- endoscopic sub-mucosal dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Feb 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OVER 18 YEARS OLD
- PATIENTS AGREED WITH THE STUDY
- SCORE ASA 1 OR 2
- Patient recorded in a social safety organism
- patients presenting with superficial lesions with an endoscopic indication of resection
Who cannot join
- under 18 years old
- Patients not agreed with the study
- pregnant women
- patient included in an another study
- medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention
- coagulation disorders
- score asa over 3
- patients with another neoplasic lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix
safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).
Read the detailed description
Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)
Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)
- Conditions
- Stomach Neoplasm, Intestinal Neoplasm, Rectal Neoplasm
- Being tested
- endoscopic sub-mucosal dissection
- Keywords
- oesophagus, stomach, intestine, rectum
- Medical subject headings
- Stomach Neoplasms, Intestinal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic sub-mucosal dissectionProcedure or surgery
endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions
| Study group | Role | What they receive |
|---|---|---|
| endoscopic sub-mucosal dissection | Experimental | Not described Receives: Procedure: endoscopic sub-mucosal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Christophe Saurin, Hôpital Edouard Herriot
- Investigators
- PINSET CHRISTIAN, CEO, Study director, SPONSOR DIRECTOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910974
- Sponsor's protocol ID
- TRESTIS 2013-A00133-42
- Other IDs
- TRESTIS
- Status last verified
- Jul 2012
- First submitted
- 15 Jul 2013
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix
- ClinicalTrials.gov ID
- NCT01910974
- Acronym / sponsor ID
- TRESTIS 2013-A00133-42
- Conditions
- Stomach Neoplasm, Intestinal Neoplasm, Rectal Neoplasm
- Keywords
- oesophagus, stomach, intestine, rectum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Jul 2013 (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.
safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).
Detailed description
Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)
Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic sub-mucosal dissection | Experimental | Procedure: endoscopic sub-mucosal dissection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- OVER 18 YEARS OLD
- PATIENTS AGREED WITH THE STUDY
- SCORE ASA 1 OR 2
- Patient recorded in a social safety organism
- patients presenting with superficial lesions with an endoscopic indication of resection
Key exclusion criteria (8 listed)
- under 18 years old
- Patients not agreed with the study
- pregnant women
- patient included in an another study
- medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention
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 |
|---|---|---|
| endoscopic sub-mucosal dissectionendoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions | Procedure or surgery | endoscopic sub-mucosal dissection |
Primary outcome
SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
Time frame: 18 months
inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 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 30 Aug 2016.
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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.
PINSET CHRISTIAN, CEO study director
SPONSOR DIRECTOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic sub-mucosal dissection in people with Stomach Neoplasm and Intestinal Neoplasm, run by Hôpital Edouard Herriot at 1 site in France.
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 5 inclusion and 8 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 30 Aug 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 France. 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?
SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE (time frame: 18 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 30 Aug 2016.