AchalasiaNCT03123835
Outcome Analysis of POEM and Endoluminal Therapies
A study testing Endoscopic Intervention in people with Achalasia and Gastric Fistula, run by University of California, Davis at 1 site in United States.
Trial summary
Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Achalasia, Gastric Fistula, Weight Gain After Primary Weight Loss Surgery
- What is being tested?
- Endoscopic Intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult male and female patients 18-80 years of age
- Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)
- Gastrointestinal Reflux Disease
- Achalasia
- Barrett's Esophagus
- Post Bariatric Surgery conditions
- Other gastrointestinal and postsurgical disorders.
Who cannot join
- Adults unable to consent
- Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Univesity of California Davis Health System
Sacramento, California, 95817
About this study
Official title: Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms
Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.
Read the detailed description
Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.
- Conditions
- Achalasia, Gastric Fistula, Weight Gain After Primary Weight Loss Surgery, Marginal Ulcer, Stenoses, Gastric Nec
- Being tested
- Endoscopic Intervention
- Keywords
- Achalasia, Fistula, Obesity, POEM, GERD, endoscopic, treatments, post bariatric surger weight gain, endoluminal, Bariatric Surgery, Barretts
- Medical subject headings
- Esophageal Achalasia, Gastric Fistula, Peptic Ulcer, Constriction, Pathologic, Fistula, Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic InterventionProcedure or surgery
Also called Endoluminal Therapies, POEM, Endoscopic Revision
After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Patients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples. Receives: Procedure: Endoscopic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in GERDDQ
Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)
Measured: 3-6 months
Secondary outcomes (1)
Decrease in Eckardt scoring
Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)
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 Apr 2017
- Study startMar 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed R Ali, MD, Principal investigator, U.C. Davis Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123835
- Sponsor's protocol ID
- 676956
- Status last verified
- Dec 2025
- First submitted
- 5 Apr 2016
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: de-identified data will be maintained until study closure. Statistical summary of data will be published with any journal articles submitted for review/approval.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms
- ClinicalTrials.gov ID
- NCT03123835
- Acronym / sponsor ID
- 676956
- Conditions
- Achalasia, Gastric Fistula, Weight Gain After Primary Weight Loss Surgery, Marginal Ulcer, Stenoses, Gastric Nec
- Keywords
- Achalasia, Fistula, Obesity, POEM, GERD, endoscopic, treatments, post bariatric surger weight gain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 21 Apr 2017 (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.
Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.
Detailed description
Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Procedure: Endoscopic InterventionPatients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult male and female patients 18-80 years of age
- Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)
- Gastrointestinal Reflux Disease
- Achalasia
- Barrett's Esophagus
Key exclusion criteria (2 listed)
- Adults unable to consent
- Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.
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 InterventionAlso: Endoluminal Therapies, POEM, Endoscopic RevisionAfter reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery. | Procedure or surgery | Treatment |
Primary outcome
Decrease in GERDDQ
Time frame: 3-6 months
Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)
1 secondary outcome
Decrease in Eckardt scoring
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. de-identified data will be maintained until study closure. Statistical summary of data will be published with any journal articles submitted for review/approval.
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Achalasia
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.
Mohamed R Ali, MD principal investigator
U.C. Davis Medical Center
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 Intervention in people with Achalasia and Gastric Fistula, run by University of California, Davis at 1 site in United States.
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 7 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: enrolling by invitation, as of the sponsor's last update on 5 Dec 2025. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Decrease in GERDDQ (time frame: 3-6 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 5 Dec 2025.