GastroparesisNCT04349670
Safety and Efficacy of GPOEM in the Treatment of Gastroparesis
An observational study of Gastroparesis and Gastroparesis Postoperative, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Gastroparesis Postoperative, Gastroparesis With Diabetes Mellitus
- What is being tested?
- GPOEM - gastric per-oral endoscopic myotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 1 Apr 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients affected with clinical or scintigrafic severe gastroparesis or patients with moderate symptoms/gastric scintigraphic delayed emptying with good response to botulinum.
Who may be able to join
- Gastroparesis (GCSI > 2 OR Gastric emptying half-time > 180 min OR gastric retention at 120 min > 60% OR good response to botulinum if former criteria not met)
Who cannot join
- Age < 18 years
- Inability to understand protocol
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.
Read the detailed description
After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol.
Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications.
Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.
- Being tested
- GPOEM - gastric per-oral endoscopic myotomy
- Keywords
- GPOEM, gastroparesis, pyloromyotomy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPOEM - gastric per-oral endoscopic myotomyProcedure or surgery
Endoscopic section of the pyloric muscle with submucosal tunnel technique.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Change in symptomatological scores
Measured: 1, 3, 6, 12, 24 months
Functional efficacy
Change of scintigraphy evaluated gastric emptying time
Measured: 3, 12, 24 months
Complications
Evaluation of the operative adverse events
Measured: peri-operative time (48 hours)
Secondary outcomes (1)
Correlation of symptoms
Evaluate the correlation between symptoms and gastric emptying
Measured: 3, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pier Alberto Testoni, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349670
- Sponsor's protocol ID
- GPOEM
- Status last verified
- May 2020
- First submitted
- 15 Apr 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of GPOEM in the Treatment of Gastroparesis
- ClinicalTrials.gov ID
- NCT04349670
- Acronym / sponsor ID
- GPOEM
- Keywords
- GPOEM, gastroparesis, pyloromyotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Apr 2020 (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.
The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.
Detailed description
After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol.
Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications.
Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients affected with clinical or scintigrafic severe gastroparesis or patients with moderate symptoms/gastric scintigraphic delayed emptying with good response to botulinum.
Key inclusion criteria (1 listed)
- Gastroparesis (GCSI > 2 OR Gastric emptying half-time > 180 min OR gastric retention at 120 min > 60% OR good response to botulinum if former criteria not met)
Key exclusion criteria (2 listed)
- Age < 18 years
- Inability to understand protocol
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 |
|---|---|---|
| GPOEM - gastric per-oral endoscopic myotomyEndoscopic section of the pyloric muscle with submucosal tunnel technique. | Procedure or surgery | – |
Primary outcome
Clinical efficacy
Time frame: 1, 3, 6, 12, 24 months
Change in symptomatological scores
Functional efficacy
Time frame: 3, 12, 24 months
Change of scintigraphy evaluated gastric emptying time
Complications
Time frame: peri-operative time (48 hours)
Evaluation of the operative adverse events
1 secondary outcome
Correlation of symptoms
Time frame: 3, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No
Related trials for Gastroparesis
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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?
An observational study of Gastroparesis and Gastroparesis Postoperative, run by IRCCS San Raffaele 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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?
Results are not available in the source record.
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?
Clinical efficacy (time frame: 1, 3, 6, 12, 24 months). The study lists 3 primary outcomes in all. 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 29 May 2020.