Esophageal StrictureINGESTNCT03885310
INGEST I Pilot Study
A study testing GIE Drug Coated Balloon in people with Esophageal Stricture, run by GIE Medical at 1 site in Paraguay.
Trial summary
INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Stricture
- What is being tested?
- GIE Drug Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteParaguay
- Study dates
- 24 Feb 2019to Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years.
- Benign esophageal stricture with diameter less than 10 mm (barium esophagram).
- Dysphagia score of 2 to 4 (Ogilvie Dysphagia Score).
- Recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions.
- Stricture total length ≤ 7 cm. Tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease.
- Ability to undergo periodic endoscopic follow-up.
- Voluntary participation and provided written informed consent.
Who cannot join
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Contraindication to endoscopy, anesthesia or deep sedation.
- Benign esophageal stricture due to extrinsic esophageal compression.
- Currently required chest radiation therapy.
- Malignant esophageal stricture.
- Stricture total length > 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm
Show all 21Show fewer
- Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, etc.
- Active erosive esophagitis.
- Present esophageal ulceration, perforation, leak, fistula, or varices.
- Concurrent gastric and/or duodenal obstruction.
- Active systemic infection.
- Allergy to paclitaxel or any components of the delivery system.
- Severe coagulation disorders or current use of anticoagulant for comorbidities.
- Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
- Received steroid injections into target stricture in the last 4 weeks
- Intolerant to proton pump inhibitors.
- Life expectancy of less than 12 months.
- Unwilling or unable to comply with the follow-up study requirements.
- Lacking capacity to provide informed consent.
- Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, recent laparotomy, pharyngeal or cervical deformity, etc.
- Currently participation in another pre-market drug or medical device clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
Read the detailed description
The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on esophageal stricture.
Up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
- Conditions
- Esophageal Stricture
- Being tested
- GIE Drug Coated Balloon
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIE Drug Coated BalloonDevice
The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.
| Study group | Role | What they receive |
|---|---|---|
| DCB Treatment | Experimental | Stricture patients treated by DCB Receives: Device: GIE Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of serious balloon dilation-related complications
Adverse events such as perforation, bleeding requiring intervention, severe pain during swallowing, infection requiring hospitalization or IV antibiotics, dysphagia requiring re-intervention at determined by the attending physician
Measured: 30 days
Secondary outcomes (5)
Numbers of additional esophageal dilation procedures
Repeat stricture treatments
Measured: 30 days, 3 months, 6 months, and 12 months
Time to first dysphagia symptom recurrence
Ogilvie Dysphagia Score will be used to assess subject's dysphagia symptom changes at follow-ups. The date of the first reported occurrence of dysphagia symptom will be used to derive the time to first dysphagia symptom recurrence.
Measured: 30 days, 3 months, 6 months, and 12 months
Improvement in dysphagia score
Ogilvie Dysphagia Score will be used to assess subject's dysphagia symptom changes at follow-ups. The scores at each follow-up will be compared to the score at baseline.
Measured: 30 days, 3 months, 6 months, and 12 months
Esophageal stricture diameter
Endoscopy and esophagography will be conducted to measure the internal caliber of the esophagus. Results will be reported in millimeters.
Measured: 30 days, 3 months, 6 months, and 12 months
Technical success
Successful delivery of the drug coated balloon to the target stricture, balloon inflation to the desired pressure, balloon deflation and withdraw without device malfunction.
Measured: Time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start24 Feb 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal StrictureStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- GIE Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885310
- Sponsor's protocol ID
- PR2001
- Acronym
- INGEST
- Status last verified
- Aug 2022
- First submitted
- 19 Mar 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang KK, Schorn I, Adorno C. Development and initial clinical experience with a paclitaxel-coated balloon for the treatment of benign difficult esophageal strictures. IGIE. 2023 Sep 17;2(4):399-407. doi: 10.1016/j.igie.2023.09.004. eCollection 2023 Dec.
PubMed 41646070
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
- ClinicalTrials.gov ID
- NCT03885310
- Acronym / sponsor ID
- INGEST / PR2001
- Conditions
- Esophageal Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GIE MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Mar 2019 (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.
INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
Detailed description
The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on esophageal stricture.
Up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB Treatment | Experimental | Device: GIE Drug Coated BalloonStricture patients treated by DCB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤ 80 years.
- Benign esophageal stricture with diameter less than 10 mm (barium esophagram).
- Dysphagia score of 2 to 4 (Ogilvie Dysphagia Score).
- Recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions.
- Stricture total length ≤ 7 cm. Tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease.
Key exclusion criteria (21 listed)
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Contraindication to endoscopy, anesthesia or deep sedation.
- Benign esophageal stricture due to extrinsic esophageal compression.
- Currently required chest radiation therapy.
- Malignant esophageal stricture.
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 |
|---|---|---|
| GIE Drug Coated BalloonThe GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers. | Device | DCB Treatment |
Primary outcome
Incident of serious balloon dilation-related complications
Time frame: 30 days
Adverse events such as perforation, bleeding requiring intervention, severe pain during swallowing, infection requiring hospitalization or IV antibiotics, dysphagia requiring re-intervention at determined by the attending physician
5 secondary outcomes
Numbers of additional esophageal dilation procedures
Time frame: 30 days, 3 months, 6 months, and 12 months
Time to first dysphagia symptom recurrence
Time frame: 30 days, 3 months, 6 months, and 12 months
Improvement in dysphagia score
Time frame: 30 days, 3 months, 6 months, and 12 months
Esophageal stricture diameter
Time frame: 30 days, 3 months, 6 months, and 12 months
Technical success
Time frame: Time of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 41646070Wang KK, Schorn I, Adorno C. Development and initial clinical experience with a paclitaxel-coated balloon for the treatment of benign difficult esophageal strictures. IGIE. 2023 Sep 17;2(4):399-407. doi: 10.1016/j.igie.2023.09.004. eCollection 2023 Dec.
- Individual participant dataSharing planned: Undecided
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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.
Kenneth Wang, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIE Drug Coated Balloon in people with Esophageal Stricture, run by GIE Medical at 1 site in Paraguay.
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 21 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 10 Aug 2022. 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 Paraguay. 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?
Incident of serious balloon dilation-related complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885310, which also lists 1 linked publication.
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 10 Aug 2022.