Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06451614 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

SpaceIT Hydrogel System for Perirectal Spacing

Study acronym: HYDROSPACE
StatusActive, Not Recruiting
PhaseNot applicable
Started2024-10-30
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 14, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 3 months later across 3 updates Jun 30, 2026 → Sep 30, 2026
See other at-risk trials from Boston Scientific Corporation

Amendment history

2026-09-10
Study Status v30
Primary completion pushed: 2026-08-30 → 2026-09-30
2026-08-10
Study Status v29
Primary completion pushed: 2026-07-30 → 2026-08-30
2026-07-15
Study Status v28
Primary completion pushed: 2026-06-30 → 2026-07-30
2026-07-10
2 amendments v26-v27
2 re-verifications since 2026-06-11, no change to tracked fields
2026-05-11
Study Status, Contacts/Locations v25
Trial sites reduced: 29 → 26 locations
2026-04-14
Study Status v24
Primary completion pushed: 2026-03-31 → 2026-06-30
2026-03-10
2 amendments v22-v23
2 re-verifications since 2026-02-24, no change to tracked fields
2026-01-30
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v21
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 29 of 29 sites
2026-01-02
Study Status, Contacts/Locations v20
Study sites28→29
2025-12-18
Study Status, Contacts/Locations v19
Study sites27→28
2025-11-17
Study Status, Contacts/Locations v18
Study sites24→27
2025-10-23
Study Status, Contacts/Locations v17
Study sites22→24
2025-09-22
Study Status, Contacts/Locations v16
Study sites20→22
2025-08-08
Study Status, Contacts/Locations v15
Study sites19→20
2025-08-05
Study Status, Contacts/Locations v14
Study sites18→19
2025-07-03
Study Status, Contacts/Locations v13
Study sites16→18
2025-06-12
Study Status, Contacts/Locations v12
Study sites13→16
2025-05-19
Study Status, Contacts/Locations v11
Study sites11→13
2025-04-24
Study Status, Contacts/Locations v10
Study sites9→11
2025-03-13
Study Status, Eligibility, Contacts/Locations v9
Study sites5→9
Eligibility criteria+188 characters
[...] ) sensitivity or allergy Known iodine sensitivity or allergy ADT, if applicable, cannot or was not started 15-60 days prior to the pre-index procedure RT planning imaging and is planned to continue for a total planned duration greater than 6 months
2025-02-18
Study Status, Contacts/Locations v8
Study sites3→5
2025-01-28
Study Status, Contacts/Locations v7
Study sites2→3
2024-12-17
Study Status, Outcome Measures, Contacts/Locations v6
Study sites1→2
Primary endpoints2 entries, revised
Primary Safety Endpoint - Acute Grade 3 or greater adverse events related to the hydrogel placement or hydrogel misplacement resulting in a delay or cancellation of radiotherapy.
2024-11-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-31→confirmed 2024-10-30
Study sites0→1
2024-10-25
Study Status v4
Re-verified, no change to tracked fields
2024-09-27
Study Status v3
Primary completion date2025-03-31→2026-03-31
2024-08-13
Study Status, Oversight, Eligibility, Contacts/Locations v2
Start date2025-01-01→2024-10-31
Eligibility criteria+462 characters
Inclusion Criteria: Subjects must meet the following criteria to be eligible for participation in the study: Age ≥18 years old Subjects must have had pathologically conf [...] of the prostate and planning to undergo EBRT Subjects must havemeet ALL of the following: Clinical stage T1-T2c (AJCC Ver. 9 8) tumor AND Gleason Score 7 or less as determined from a bio [...] sterior extracapsular extension (ECE) of the prostate cancer Note: MRI must be taken within 6 months prior to the Baseline visit Subjects who have metastatic disease, other ongoing cancers [...] screening History of transurethral prostate surgery (e. [...]
2024-07-17
Study Status v1
Primary completion date2025-12-31→2025-03-31
Completion date2026-12-31→2028-03-31
Start date2024-10-01→2025-01-01
2024-06-04
Original filing
To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
Trial Details
NCT Number NCT06451614
Lead Sponsor Boston Scientific Corporation
Conditions Prostate Cancer
Enrollment 230 participants
Start Date 2024-10-30
Primary Completion 2026-09-30 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-14