NCT06571669ClinicalTrials.gov

BOOM-IBD2 Pivotal Clinical Trial

BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.

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Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends…

Interventionell137 Teilnehmende gesucht19 Studienzentren1 Land

Kategorien

Gastroenterologie und Hepatologie96%Dermatologie4%

In 1 Register registriert

ClinicalTrials.govNCT06571669Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert letzten Monat

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-08-26; recorded start 2025-01-31
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Boomerang Medical)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 19 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study: 137 participants (target), run at 19 sites.

How this score is built

Enrolment20/40
137 participants (target)
Site count15/25
19 sites
Country count0/15
Single country
Planned duration8/10
Planned over about 34 months
Sponsor scale0/10
Boomerang Medical has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

The main goal is to find out if bowel urgency gets better after 12 weeks, using a standard rating scale for bowel urgency. Adults ages 18 to 85 with ulcerative colitis may be able to join. Everyone in the study gets the device. There is no placebo group. Study visits continue for 12 months.

Erkrankungen

Ulcerative Colitis
Inflammatory Bowel Diseases

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – 85 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: * Male or female * 18 to 85 years of age * Diagnosed with ulcerative colitis * Ability and willingness to consent to participate by signing the informed consent form * Ability to comply with the protocol and willingness to comply with all follow up requirements Exclusion Criteria: * Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study * Any psychiatric or personality disorder at the discretion of the study investigator * Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess) * Active clostridium difficile infection of the colon * Active cytomegalovirus (CMV) infection of the colon * Evidence of colonic perforation * Fulminant colitis requiring emergency surgery * Microscopic, ischemic or infectious colitis * Unresected neoplasia of the colon * Colonic stricture unable to pass a colonoscope * Current evidence of cancer in the gastrointestinal tract * Current participation in another clinical trial * Previous history of surgery for ulcerative colitis, or probably to require such intervention * Previously implanted with a neurostimulation device or participated in a neurostimulation trial * Inability to operate the patient programmer

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Nicht zutreffend
Interventionsmodell	SINGLE_GROUP
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	137 Teilnehmende gesucht

Sponsor und Mitwirkende

Boomerang Medical Sponsor

Studienarme und Interventionen

Treatment ArmEXPERIMENTAL
Patients implanted with neuromodulation

Interventionen

Medizinprodukt Neuromodulation
Neuromodulation

Endpunkte

Primärer Endpunkt
Bowel Urgency
Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.
Zeitrahmen 12 weeks

Daten

Daten
Startdatum	31. Januar 2025 (tatsächlich)
Primärer Abschluss	28. Februar 2027 (geschätzt)
Abschluss	30. November 2027 (geschätzt)
Erstveröffentlichung	26. August 2024 (tatsächlich)
Zuletzt aktualisiert	6. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

16 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Amarillo Premier Research (Objective Health)	Amarillo	Texas	Rekrutiert
UNC Chapel Hill	Chapel Hill	North Carolina	Rekrutiert
Columbia Digestive Health Research (Objective Health)	Columbia	South Carolina	Rekrutiert
Gastroenterology Medical Clinic (Objective Health)	Folsom	California	Rekrutiert
GI Alliance	Jackson	Mississippi	Rekrutiert
Las Vegas Medical Research LLC, DBA Vector Clinical Trials	Las Vegas	Nevada	Rekrutiert
Center for Colorectal Innovation	Los Angeles	California	Rekrutiert
Northwell Health North Shore University Hospital	Manhasset	New York	Rekrutiert
Great Lakes Gastro	Mentor	Ohio	Zurückgezogen
Columbia University Irving Medical Center/New York Presbyterian Hospital	New York	New York	Rekrutiert
Hoag Hospital	Newport Beach	California	Rekrutiert
PAMF (Palo Alto Medical Foundation)	Palo Alto	California	Rekrutiert
Pennsylvania Hospital	Philadelphia	Pennsylvania	Rekrutierung noch nicht begonnen
Sanford Health	Sioux Falls	South Dakota	Rekrutiert
Gateway GI Research (Objective Health)	St Louis	Missouri	Rekrutiert
Digestive Research of Central Texas (Objective Health)	Waco	Texas	Rekrutiert
Kansas Gastro	Wichita	Kansas	Rekrutiert
Digestive Health Research of North Texas (Objective Health)	Wichita Falls	Texas	Aktiv, rekrutiert nicht
MN Urology	Woodbury	Minnesota	Rekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

https://xmedica.io/trials/ctgov/NCT06571669