Prospective Study , QuestionairesNCT07859514
Prospective Study To Assess The Outcomes Of Nitrous Oxide Cryoablation For Treatment Of Duodenal Adenomas In Patients With Hereditary Conditions Such As FAP, HNPCC
A study testing Esophagogastroduodenoscopy in people with Prospective Study , Questionaires and Outcomes, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn how well nitrous oxide cryoballoon ablation, a procedure that uses extreme cold to destroy abnormal tissue, works in treating flat duodenal adenomas (abnormal growths in the small intestine) in people with FAP or Lynch syndrome (HNPCC). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Prospective Study , Questionaires, Outcomes, Nitrous Oxide
- What is being tested?
- Esophagogastroduodenoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2027to 1 Jan 2032
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Presence of invasive duodenal cancer.
- Severe comorbidities that would contraindicate endoscopic procedures.
- Allergy or intolerance to components of the nitrous oxide cryoballoon system.
- Previous duodenal surgery affecting the study area.
- Active gastrointestinal bleeding. Pregnancy
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
UT MD Anderson Cancer Center
Houston, Texas, 77030
Marta Davila, MD, 713-563-4382, MDavila@mdanderson.org
Marta Davila, MD
About this study
To learn how well nitrous oxide cryoballoon ablation, a procedure that uses extreme cold to destroy abnormal tissue, works in treating flat duodenal adenomas (abnormal growths in the small intestine) in people with FAP or Lynch syndrome (HNPCC).
Read the detailed description
Primary Objectives Evaluate the Efficacy of Nitrous Oxide Cryoballoon Ablation: To determine the clinical efficacy of nitrous oxide cryoballoon ablation in achieving complete eradication of duodenal adenomas in patients with Familial Adenomatous Polyposis (FAP) and Hereditary Non-Polyposis Colorectal Cancer (HNPCC). The primary endpoint will be the complete eradication of adenomas at 12 months post-procedure, confirmed by endoscopy and histology.
- Conditions
- Prospective Study , Questionaires, Outcomes, Nitrous Oxide, Cryoablation, Duodenal Adenoma, Hereditary Conditions
- Being tested
- Esophagogastroduodenoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopyProcedure or surgery
Esophagogastroduodenoscopy with cryoballoon ablation will be performed every 3 months to a maximum of 5 procedures.
| Study group | Role | What they receive |
|---|---|---|
| EGD + CBA | Experimental | Endoscopy with Cryoballoon Ablation Treatment of Duodenal Adenomas Receives: Procedure: Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start3 Mar 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective Study , QuestionairesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Davila, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859514
- Sponsor's protocol ID
- 2026-0068
- Other IDs
- NCI-2026-07329
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study To Assess The Outcomes Of Nitrous Oxide Cryoablation For Treatment Of Duodenal Adenomas In Patients With Hereditary Conditions Such As FAP, HNPCC
- ClinicalTrials.gov ID
- NCT07859514
- Acronym / sponsor ID
- 2026-0068
- Conditions
- Prospective Study , Questionaires, Outcomes, Nitrous Oxide, Cryoablation, Duodenal Adenoma, Hereditary Conditions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Mar 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 5 Oct 2026 (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.
To learn how well nitrous oxide cryoballoon ablation, a procedure that uses extreme cold to destroy abnormal tissue, works in treating flat duodenal adenomas (abnormal growths in the small intestine) in people with FAP or Lynch syndrome (HNPCC).
Detailed description
Primary Objectives Evaluate the Efficacy of Nitrous Oxide Cryoballoon Ablation: To determine the clinical efficacy of nitrous oxide cryoballoon ablation in achieving complete eradication of duodenal adenomas in patients with Familial Adenomatous Polyposis (FAP) and Hereditary Non-Polyposis Colorectal Cancer (HNPCC). The primary endpoint will be the complete eradication of adenomas at 12 months post-procedure, confirmed by endoscopy and histology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGD + CBA | Experimental | Procedure: EsophagogastroduodenoscopyEndoscopy with Cryoballoon Ablation Treatment of Duodenal Adenomas |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Presence of invasive duodenal cancer.
- Severe comorbidities that would contraindicate endoscopic procedures.
- Allergy or intolerance to components of the nitrous oxide cryoballoon system.
- Previous duodenal surgery affecting the study area.
- Active gastrointestinal bleeding. Pregnancy
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 |
|---|---|---|
| EsophagogastroduodenoscopyEsophagogastroduodenoscopy with cryoballoon ablation will be performed every 3 months to a maximum of 5 procedures. | Procedure or surgery | EGD + CBA |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 Oct 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Marta Davila, MD principal investigator
UT MD Anderson Cancer 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 Esophagogastroduodenoscopy in people with Prospective Study , Questionaires and Outcomes, run by M.D. Anderson Cancer Center 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 0 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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?
Contact Marta Davila, MD (713-563-4382, MDavila@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). 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 Oct 2026.