Safety and Efficacy of GPOEM in the Treatment of Gastropa... | NCT04349670

Studies
Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

NCT04349670

Sponsor

IRCCS San Raffaele

Status

Unknown status

Last Update Posted

May 29, 2020Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Gastroparesis
Gastroparesis Postoperative
Gastroparesis With Diabetes Mellitus

Interventions

GPOEM - gastric per-oral endoscopic myotomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Estimated

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2020

Last Update Posted Date

May 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GPOEM - gastric per-oral endoscopic myotomy	Procedure	Endoscopic section of the pyloric muscle with submucosal tunnel technique.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical efficacy	Change in symptomatological scores	1, 3, 6, 12, 24 months
Functional efficacy	Change of scintigraphy evaluated gastric emptying time	3, 12, 24 months
Complications	Evaluation of the operative adverse events	peri-operative time (48 hours)

Secondary Outcomes

Measure	Description	Time Frame
Correlation of symptoms	Evaluate the correlation between symptoms and gastric emptying	3, 12, 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Age < 18 years
Inability to understand protocol

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pier Alberto Testoni		Milan		20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018589	Gastroparesis

Ancestor Terms

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010243	Paralysis

Browse Leaves

Not provided

Browse Branches

Not provided